National recall alert center immediate warning alert notification the following have been recalled or are subject to field correction or safety notice



Download 177.19 Kb.
Date conversion08.07.2018
Size177.19 Kb.

NRAC Issue #2144 March 8, 2017 19 Pages

NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION

THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO

FIELD CORRECTION OR SAFETY NOTICE

THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC
SUMMARY PAGE
MEDICAL DEVICES

PRODUCT Abdominoplasty Pack, etc

MANUFACTURER Windstone Medical Packaging, Inc

PAGE 4
PRODUCT Advia Centaur® Systems, Progesterone, Immunoassay

MANUFACTURER Siemens Healthcare Diagnostics, Inc

PAGE 12
PRODUCT Cardio software

MANUFACTURER Merge Healthcare, Inc

PAGE 14
PRODUCT CaviWipes1 Extra Large

MANUFACTURER Metrex Research, LLC

PAGE 13
PRODUCT Contact lenses, color

MANUFACTURER The See Clear Company

PAGE 14
PRODUCT Covidien Curity™ eye pad, etc

MANUFACTURER Medtronic

PAGE 16
PRODUCT External Catheter for Women-Wick

MANUFACTURER Purewick Corporation

PAGE 15
PRODUCT Femoral Driver

MANUFACTURER United Orthopedic Corporation

PAGE 11
PRODUCT Haemophilus Test Medium (Agar)

MANUFACTURER Remel Inc

PAGE 13
PRODUCT iChemVELOCITY Urine Chemistry System

MANUFACTURER Beckman Coulter Inc

PAGE 10
PRODUCT Knee, Hip and Nail Implants

MANUFACTURER Zimmer Biomet, Inc

PAGE 15
PRODUCT K-Wires

MANUFACTURER MicroAire Surgical Instruments, LLC

PAGE 13
PRODUCT Left Double Lumen Endobronchial Tube with Parker Flex-Tip

MANUFACTURER Parker Medical

PAGE 13
PRODUCT Picture Archive Communication System (PACS)

MANUFACTURER McKesson Medical Imaging

PAGE 12
PRODUCT Premier Buffer B Reagent

MANUFACTURER Trinity Biotech

PAGE 12
PRODUCT Premier Guard Sterile Drape

MANUFACTURER Covidien LLC

PAGE 14
PRODUCT ProBP 2400 Digital NIBP Device

MANUFACTURER Microlife USA, Inc

PAGE 16
PRODUCT RIO THA Application User Guides

MANUFACTURER Mako Surgical Corporation

PAGE 16
PRODUCT Sonnet Mini Battery Pack

MANUFACTURER MED-EL Elektromedizinische Gereate, Gmbh

PAGE 12
PRODUCT TotalCare® Bed System with 3-Level Patient Position Monitoring (PPM)

MANUFACTURER Hill-Rom, Inc

PAGE 14
PRODUCT Triforce® Peripheral Crossing Set

MANUFACTURER Cook Medical, Inc

PAGE 15
PRODUCT UNI-CP System

MANUFACTURER Integra LifeSciences Corp

PAGE 14
PRODUCT Various Needles

MANUFACTURER CareFusion

PAGE 10
PHARMACEUTICALS


PRODUCT Alfuzosin Hydrochloride Extended-release Tablets

MANUFACTURER Sun Pharmaceutical Industries, Inc

PAGE 19
PRODUCT CycloSPORINE Capsules

MANUFACTURER Amerisource Health Services

PAGE 18
PRODUCT DESONIDE OIN 0.05% 60GM

MANUFACTURER Fougera Pharmaceuticals Inc

PAGE 17
PRODUCT Duopa (carbidopa and levodopa enteral suspension)

MANUFACTURER AbbVie Inc

PAGE 18
PRODUCT Eye Irrigating Solution, etc

MANUFACTURER United Exchange Corporation

PAGE 17
PRODUCT Eye Wash

MANUFACTURER United Exchange Corporation

PAGE 17
PRODUCT glipiZIDE Extended-Release Tablets, etc

MANUFACTURER Mylan Pharmaceuticals Inc

PAGE 17
PRODUCT HealthA2Z Chewable Aspirin (NSAID) 81 mg

MANUFACTURER Allegiant Health

PAGE 18
PRODUCT Salicylic Acid Shampoo & Cream

MANUFACTURER L Perrigo Company

PAGE 18

----------------------------------------------------------------------------------------------------------------------------------------------


PRODUCT 1) Abdominoplasty Pack

RECALL NUMBER Z-1258-2017

PRODUCT 2) Angio Pack

RECALL NUMBER Z-1259-2017

PRODUCT 3) Anterior Cervical Fusion Pack

RECALL NUMBER Z-1260-2017

PRODUCT 4) Arthroscopy Pack

RECALL NUMBER Z-1261-2017

PRODUCT 5) Arthroscopy Pack

RECALL NUMBER Z-1262-2017

PRODUCT 6) Augmentation Pack

RECALL NUMBER Z-1263-2017

PRODUCT 7) Basic Extended Pack

RECALL NUMBER Z-1264-2017

PRODUCT 8) Basic Face Kit

RECALL NUMBER Z-1265-2017

PRODUCT 9) Basic Kit

RECALL NUMBER Z-1266-2017

PRODUCT 10) Basic Pack

RECALL NUMBER Z-1267-2017

PRODUCT 11) Basic Pack (1185)

RECALL NUMBER Z-1268-2017

PRODUCT 12) Basic Setup Pack

RECALL NUMBER Z-1269-2017

PRODUCT 13) Basic Setup Tray

RECALL NUMBER Z-1270-2017

PRODUCT 14) Basic Tray

RECALL NUMBER Z-1271-2017

PRODUCT 15) Basin Pack

RECALL NUMBER Z-1272-2017

PRODUCT 16) Bayview Abdominoplasty Pack

RECALL NUMBER Z-1273-2017

PRODUCT 17) Bayview Breast Pack

RECALL NUMBER Z-1274-2017

PRODUCT 18) Bleph Pack

RECALL NUMBER Z-1275-2017

PRODUCT 19) Breast Augmentation Pack

RECALL NUMBER Z-1276-2017

PRODUCT 20) Breast Pack

RECALL NUMBER Z-1277-2017

PRODUCT 21) Breast Recon Pack

RECALL NUMBER Z-1278-2017

PRODUCT 22) Brow Pack

RECALL NUMBER Z-1279-2017

PRODUCT 23) Catheter Pack

RECALL NUMBER Z-1280-2017

PRODUCT 24) Chest Breast Drape

RECALL NUMBER Z-1281-2017

PRODUCT 25) C-Tray Pack

RECALL NUMBER Z-1282-2017

PRODUCT 26) Custom Breast Augmentation Pack

RECALL NUMBER Z-1283-2017

PRODUCT 27) Custom Pack

RECALL NUMBER Z-1284-2017

PRODUCT 28) Custom Pack with Introducer Kit

RECALL NUMBER Z-1285-2017

PRODUCT 29) Custom Venous Kit

RECALL NUMBER Z-1286-2017

PRODUCT 30) D & C Kit

RECALL NUMBER Z-1287-2017

PRODUCT 31) D & C Pack

RECALL NUMBER Z-1288-2017

PRODUCT 32) D&C/Cysto Pack

RECALL NUMBER Z-1289-2017

PRODUCT 33) Dr Bragg Vein Tray, RX

RECALL NUMBER Z-1290-2017

PRODUCT 34) Dr. Casey Pack

RECALL NUMBER Z-1291-2017

PRODUCT 35) Dr. Landi EVLT Pack

RECALL NUMBER Z-1292-2017

PRODUCT 36) Dr. Newman Surgical Procedure Pack

RECALL NUMBER Z-1293-2017

PRODUCT 37) ENT Pack

RECALL NUMBER Z-1294-2017

PRODUCT 38) Extremity Pack

RECALL NUMBER Z-1295-2017

PRODUCT 39) Extremity Pack (1344)

RECALL NUMBER Z-1296-2017

PRODUCT 40) Extremity Pack-N Brunswick

RECALL NUMBER Z-1297-2017

PRODUCT 41) Eye Plastic Tray

RECALL NUMBER Z-1298-2017

PRODUCT 42) Eye Tray

RECALL NUMBER Z-1299-2017

PRODUCT 43) Facial Pack

RECALL NUMBER Z-1300-2017

PRODUCT 44) Facial Plastic Pack

RECALL NUMBER Z-1301-2017

PRODUCT 45) Facial Tray

RECALL NUMBER Z-1302-2017

PRODUCT 46) Foot Pack

RECALL NUMBER Z-1303-2017

PRODUCT 47) General Laparoscopy Pack

RECALL NUMBER Z-1304-2017

PRODUCT 48) General Pack

RECALL NUMBER Z-1305-2017

PRODUCT 49) General Plastic Pack

RECALL NUMBER Z-1306-2017

PRODUCT 50) General Plastics Pack

RECALL NUMBER Z-1307-2017

PRODUCT 51) General Surgery Pack

RECALL NUMBER Z-1308-2017

PRODUCT 52) GYN Lap Pack

RECALL NUMBER Z-1309-2017

PRODUCT 53) GYN Pack

RECALL NUMBER Z-1310-2017

PRODUCT 54) Hand Pack

RECALL NUMBER Z-1311-2017

PRODUCT 55) Hand Tray

RECALL NUMBER Z-1312-2017

PRODUCT 56) Head Pack

RECALL NUMBER Z-1313-2017

PRODUCT 57) Head/Neck Pack

RECALL NUMBER Z-1314-2017

PRODUCT 58) Hernia Pack

RECALL NUMBER Z-1315-2017

PRODUCT 59) Hip Pack (1347)

RECALL NUMBER Z-1316-2017

PRODUCT 60) HSG Pack

RECALL NUMBER Z-1317-2017

PRODUCT 61) Hystero Pack

RECALL NUMBER Z-1318-2017

PRODUCT 62) Hysteroscopy Pack

RECALL NUMBER Z-1319-2017

PRODUCT 63) Knee Arthroscopy Pack

RECALL NUMBER Z-1320-2017

PRODUCT 64) Knee Pack

RECALL NUMBER Z-1321-2017

PRODUCT 65) Knee Scope Pack

RECALL NUMBER Z-1322-2017

PRODUCT 66) Laminectomy Pack

RECALL NUMBER Z-1323-2017

PRODUCT 67) Lap Band Pack

RECALL NUMBER Z-1324-2017

PRODUCT 68) Lap Chole Pack (6037)

RECALL NUMBER Z-1325-2017

PRODUCT 69) Lap Gallbladder Pack

RECALL NUMBER Z-1326-2017

PRODUCT 70) Lap Minor Pack (1346)

RECALL NUMBER Z-1327-2017

PRODUCT 71) Lap Pack

RECALL NUMBER Z-1328-2017

PRODUCT 72) Lap/Pelviscopy Pack

RECALL NUMBER Z-1329-2017

PRODUCT 73) Laparoscopic Pack

RECALL NUMBER Z-1330-2017

PRODUCT 74) Laparoscopy Pack (1184)

RECALL NUMBER Z-1331-2017

PRODUCT 75) Laparotomy Pack

RECALL NUMBER Z-1332-2017

PRODUCT 76) Lipo Pack

RECALL NUMBER Z-1333-2017

PRODUCT 77) Liposuction Pack

RECALL NUMBER Z-1334-2017

PRODUCT 78) Lower Extremity Pack

RECALL NUMBER Z-1335-2017

PRODUCT 79) Lumbar Laminectomy Pack

RECALL NUMBER Z-1336-2017

PRODUCT 80) Major Breast Pack

RECALL NUMBER Z-1337-2017

PRODUCT 81) Major Kit

RECALL NUMBER Z-1338-2017

PRODUCT 82) Major Laparotomy Pack

RECALL NUMBER Z-1339-2017

PRODUCT 83) Major Pack (1345)

RECALL NUMBER Z-1340-2017

PRODUCT 84) Minor Pack

RECALL NUMBER Z-1341-2017

PRODUCT 85) Minor Procedure Pack

RECALL NUMBER Z-1342-2017

PRODUCT 86) Minor Tray

RECALL NUMBER Z-1343-2017

PRODUCT 87) Minor/General/Ortho Pack

RECALL NUMBER Z-1344-2017

PRODUCT 88) Morris Hysto Pack

RECALL NUMBER Z-1345-2017

PRODUCT 89) Morris Lap Pack

RECALL NUMBER Z-1346-2017

PRODUCT 90) Nasal Pack

RECALL NUMBER Z-1347-2017

PRODUCT 91) Newport Coast Basic Pack

RECALL NUMBER Z-1348-2017

PRODUCT 92) Ocular Plastic Pack

RECALL NUMBER Z-1349-2017

PRODUCT 93) Open Procedure Pack

RECALL NUMBER Z-1350-2017

PRODUCT 94) Open Procedure Pack II

RECALL NUMBER Z-1351-2017

PRODUCT 95) Opgrande Hand Pack

RECALL NUMBER Z-1352-2017

PRODUCT 96) Orbitofacial Pack

RECALL NUMBER Z-1353-2017

PRODUCT 97) Ortho Minor Pack

RECALL NUMBER Z-1354-2017

PRODUCT 98) Ortho Pack

RECALL NUMBER Z-1355-2017

PRODUCT 99) Pacemaker Kit

RECALL NUMBER Z-1356-2017

PRODUCT 100) Percutaneous Entry Kit

RECALL NUMBER Z-1357-2017

PRODUCT 101) Peri GYN

RECALL NUMBER Z-1358-2017

PRODUCT 102) Plastic General Pack

RECALL NUMBER Z-1359-2017

PRODUCT 103) Plastic Kit

RECALL NUMBER Z-1360-2017

PRODUCT 104) Plastic Pack

RECALL NUMBER Z-1361-2017

PRODUCT 105) Plastic Surgery Pack

RECALL NUMBER Z-1362-2017

PRODUCT 106) Podiatry Pack

RECALL NUMBER Z-1363-2017

PRODUCT 107) Reduction Mammoplasty Pack

RECALL NUMBER Z-1364-2017

PRODUCT 108) Robotic Pack

RECALL NUMBER Z-1365-2017

PRODUCT 109) Set Up Pack

RECALL NUMBER Z-1366-2017

PRODUCT 110) Set-Up Pack

RECALL NUMBER Z-1367-2017

PRODUCT 111) Shoulder Arthroscopy Pack

RECALL NUMBER Z-1368-2017

PRODUCT 112) Shoulder Pack

RECALL NUMBER Z-1369-2017

PRODUCT 113) Spine Pack

RECALL NUMBER Z-1370-2017

PRODUCT 114) Stem Pack

RECALL NUMBER Z-1371-2017

PRODUCT 115) Surgical Pack

RECALL NUMBER Z-1372-2017

PRODUCT 116) Total Hip Pack

RECALL NUMBER Z-1373-2017

PRODUCT 117) Total Joint Pack

RECALL NUMBER Z-1374-2017

PRODUCT 118) Total Knee Pack (15710)

RECALL NUMBER Z-1375-2017

PRODUCT 119) Transvaginal Pack

RECALL NUMBER Z-1376-2017

PRODUCT 120) Universal Pack

RECALL NUMBER Z-1377-2017

PRODUCT 121) Upper Extremity Pack

RECALL NUMBER Z-1378-2017

PRODUCT 122) Upper Torso Tray

RECALL NUMBER Z-1379-2017

PRODUCT 123) Vascular Pack

RECALL NUMBER Z-1380-2017

PRODUCT 124) Vein Tray

RECALL NUMBER Z-1381-2017


CODE Part number: 1) AMS3326, AMS4381(B; 2) AMS6711; 3) AMS2502(A, AMS2502(C; 4) AMS2938, AMS3639, AMS4765, PSS1799, PSS1845(A; 5) AMS6559; 6) AMS6370; 7) AMS4421(A, AMS4421(B; 8) PS517A(D; 9) CMP1109(A; 10) AMS1868(B, AMS2608(A, AMS3861, AMS4309, PSS1833, PSS1833(A, PSS1848(A; 11) AMS6560; 12) AMS1787(A, AMS6519; 13) AMS6414; 14) PSS1559(A; 15) AMS2497; 16) 009079-1; 17) 009080-2; 18) AMS3325(B; 19) AMS1786(A, AMS2790(A, AMS3324(B, AMS4382, AMS4382(A, AMS4382(B, AMS4392, PSS3430; 20) AMS3238(A, AMS4419(A, AMS4419(B, AMS5750, AMS5750(A, AMS6120, PSS1784(B, PSS2272(A; 21) AMS5698, AMS5698(A; 22) PSS1785(C; 23) AMS4399(A; 24) AMS5853; 25) PSS2707(A; 26) PSS2455(D; 27) AMS4776, AMS4776(A, AMS5643, AMS5643(A, AMS6012, AMS6383, PSS2135(B, PSS2798(B, PSS2798(C, PSS3463; 28) TVS4011NI(L; 29) TVS4024(C; 30) CMP1466(A; 31) AMS4796(A; 32) PSS3257(D; 33) 007912-8; 34) AMS4313(A; 35) AMS1483(E; 36) PSS1689(A; 37) AMS3237(A, AMS4214; 38) AMS3240, AMS4764, AMS4788(A, PSS1798(A, PSS1842(A, PSS2706, PSS2706(A; 39) AMS6561; 40) PSS1866(A; 41) PSS1931(A; 42) PSS1834, PSS1834(A; 43) AMS6501; 44) AMS3327(C; 45) PSS1558(A; 46) AMS3637; 47) AMS4798, AMS4798(A; 48) AMS2967(A, AMS3239(A, AMS3709(B, AMS5341, AMS5694; 49) PSS2432(A; 50) 008617-1; 51) PSS1380(A; 52) PSS2194(B; 53) AMS4013(A; 54) AMS3640, AMS4213(A, AMS4311(A, AMS5343, PSS1843(A; 55) PSS2365(F, PSS2365(G; 56) PSS1934(B; 57) AMS6121; 58) AMS3859; 59) AMS6564; 60) PSS3287; 61) PSS3535(A; 62) AMS4797, AMS4797(A, AMS4797(B; 63) AMS2610(A, AMS3236(A, AMS3860; 64) AMS4211; 65) AMS2498(A, AMS2498(B, AMS2498(C; 66) PSS1844(B; 67) AMS1785(A; 68) AMS6567; 69) AMS3707; 70) AMS6566; 71) AMS4801; 72) PSS3256(B; 73) AMS2499, AMS2499(A, AMS2499(B; 74) AMS6562; 75) 006268-9, AMS4418(A, PSS2190(A; 76) AMS4420(A; 77) AMS3323(B, AMS5684, AMS5699; 78) AMS4669; 79) AMS2501, AMS2501(A, AMS2501(B; 80) AMS3409(B; 81) PHC1307(A; 82) AMS4347; 83) AMS6565; 84) AMS3782(B, AMS3782(C, CMP1560, PSS3518(B, PSS3541(A; 85) AMS4799; 86) AMS2685; 87) PSS3258(B; 88) PSS3198(A; 89) PSS3199(A; 90) PSS2186; 91) 007484-1; 92) AMS3868(A; 93) AMS4596, AMS4596(A, AMS4596(B; 94) RMS1740(A; 95) AMS4767; 96) AMS5850(A; 97) AMS3710(A; 98) PSS3466(A; 99) AMS4281, AMS4281(A, AMS4281(C, AMS4281(D; 100) TVS4022(D, TVS4022(E, TVS4022(F; 101) PSS2193(A; 102) AMS4215; 103) CMP1084(C; 104) PSS2462, PSS3319, PSS3319(A; 105) AMS5685; 106) AMS2778, AMS2778(A, AMS3785(B, AMS3785(C, AMS4011(A, PSS3422(A; 107) AMS4380, AMS4380(B; 108) AMS4389; 109) PSS3574(A; 110) PSS1305(C; 111) AMS2496(A, AMS2496(B, AMS2496(C, AMS2609, AMS3857, AMS4766, AMS4766(A, AMS4766(B; 112) AMS2936, AMS3638, AMS3711(B, AMS4212, AMS6460, PSS1852(A; 113) AMS3753(A, AMS3783(A, AMS3783(B, AMS6472; 114) AMS5166; 115) PSS3540(A; 116) PSS2956; 117) 006358-6; 118) AMS6563; 119) CMP1767; 120) AMS2036; 121) AMS4670, AMS4670(A; 122) PSS1554(B; 123) AMS4030, AMS4030(A; 124) AMS6312



MANUFACTURED & RECALLED BY Windstone Medical Packaging, Inc, Billings, MT

QUANTITY 1) 45 kits, 2) 174 kits, 3) 51 kits, 4) 1081 kits, 5) 60 kits, 6) 60 kits, 7) 170 kits, 8) 965 kits, 9) 216 kits, 10) 2388 kits, 11) 50 kits, 12) 276 kits, 13) 60 kits, 14) 69 kits, 15) 648 kits, 16) 35 kits, 17) 126 kits, 18) 16 kits, 19) 1436 kits, 20) 369 kits, 21) 96 kits, 22) 36 kits, 23) 1116 kits, 24) 60 kits, 25) 66 kits, 26) 229 kits, 27) 4155 kits, 28) 840 kits, 29) 544 kits, 30) 136 kits, 31) 24 kits, 32) 380 kits, 33) 120 kits, 34) 66 kits, 35) 944 kits, 36) 24 kits, 37) 390 kits, 38) 810 kits, 39) 60 kits, 40) 10 kits, 41) 310 kits, 42) 310 kits, 43) 24 kits, 44) 15 kits, 45) 84 kits, 46) 40 kits, 47) 36 kits, 48) 1501 kits, 49) 10 kits, 50) 465 kits, 51) 80 kits, 52) 5 kits, 53) 20 kits, 54) 1026 kits, 55) 1416 kits, 56) 40 kits, 57) 24 kits, 58) 228 kits, 59) 40 kits, 60) 300 kits, 61) 32 kits, 62) 130 kits, 63) 700 kits, 64) 150 kits, 65) 156 kits, 66) 291 kits, 67) 252 kits, 68) 39 kits, 69) 225 kits, 70) N/A, 71) 36 kits, 72) 168 kits, 73) 1056 kits, 74) 28 kits, 75) 331 kits, 76) 8 kits, 77) 35 kits, 78) 198 kits, 79) 123 kits, 80) 40 kits, 81) 85 kits, 82) 32 kits, 83) 39 kits, 84) 665 kits, 85) 365 kits, 86) 80 kits, 87) 140 kits, 88) 156 kits, 89) 25 kits, 90) 16 kits, 91) 152 kits, 92) 100 kits, 93) 1125 kits, 94) 160 kits, 95) 48 kits, 96) 60 kits, 97) 664 kits, 98) 84 kits, 99) 561 kits, 100) 350 kits, 101) 120 kits, 102) 55 kits, 103) 580 kits, 104) N/A, 105) 120 kits, 106) 2018 kits, 107) 35 kits, 108) 57 kits, 109) 820 kits, 110) 1275 kits, 111) 606 kits, 112) 875 kits, 113) 286 kits, 114) 16 kits, 115) 88 kits, 116) 33 kits, 117) 14 kits, 118) 60 kits, 119) 650 kits, 120) 15 kits, 121) 1787 kits, 122) 222 kits, 123) 360 kits, 124) 60 kits

DISTRIBUTION AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, WA

REASON The Medtronic Cover Light Handle Disposable Gloves of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Various Needles

RECALL NUMBER To be determined


CODE Catalog number: 4330, SN1015X, SN1016X, SN1017X, SN7016X, TIN3015, T1N3018, TJC3513, TJC4008, TJC4011, TJC6008, TJC6011, TJM3513, TJM4008, TJM4011, TJMS008, TJM6011, TPK1001;



lot number: 0000837810, 0000840335, 0000842213, 0000848531, 0000851181, 0000853962, 840334, 848028, 848018, 848017, 0000836578, 0000838953, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849716,0000850938, 0000852076, 0000854859, 0000838574, 0000841212, 000085078, 0000848831, 0000851431, 0000854858, 0000841227, 0000846708, 0000848560, 0000849684, 0000853455, 0000840687, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121, 0000841216, 0000848569, 0000851432, 00000852122, 0000853458, 0000841124, 0000848571, 0000853975, 0000836582, 0000838949, 0000843968, 0000849685, 0000852933, 0000841349, 0000841348, 0000843961, 0000849132, 0000852123, 0000853877, 0000836575, 0000838950, 0000840195, 0000843075, 0000843076, 0000846708, 0000852932, 0000853878, 0000854861, 854983, 0000842725, 0000853971, 0000843077, 0000849713, 0000854659, 0000837811, 0000842215, 0000840336, 0000851185

MANUFACTURED & RECALLED BY CareFusion, Vernon Hills, IL

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Packaging integrity, ie open seal.
----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT iChemVELOCITY Urine Chemistry System

RECALL NUMBER Z-1384-2017




CODE Catalog number 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061; serial number V01257, V02416, V02619, V01444, V02906, V02959, V03934, V03933, V02027, V02022, V04322, V03288, V03314, V02330, V02326, V02329, V02642, V02323, V03571, V03428, V02909, V01251, V01115, V02081, V02248, V03575, V03854, V03403, V04387, V04388, V01406, V01556, V04328, V04390, V01557, V04141, V02103, V01214, V04227, V02438, v01838, V04284, V02535, V02534, V02449, V04312, V02538, V02635, V02530, V02450, V02634, V02485, V02436, V02614, V02463, V02652, V02502, V02536, V02464, V02423, V02435, V02432, V02649, V02459, V02537, V03883, V01689, V03409, V03413, V01753, V01754, V02243, V02985, V02242, V03976, V03851, V03925, V04369, V02026, V03848, V01404, V02430, V03565, V02234, V02373, V01829, V02446, V02703, V01429, V02949, V02899, V04309, V01318, V01546, V04257, V03566, V01548, V01547, V02753, V01541, V01542, V02369, V03922, V01555, V02181, V02070, V01762, V04357, V04350, V04349, V04356, V04291, V01720, V03834, V02335, V03798, V01911, V01998, V03567, V04258, V03238, V04329, V03327, V01776, V01712, V03271, V01966, V01824, V02086, V01467, V03100, V01872, V04138, V02047, V02210, V03221, V03003, V03285, V03283, V02025, V01179, V01182, V03033, V02361, V01842, V02931, V01717, V04377, V03776, V01831, V03890, V01335, V01567,V01568, V03237, V03000, V02998, V03464, V02046, V01581, V01493, V03842, V04379, V01460, V04348, V03113, V01146, V01781, V04302, V01558, V04195, V03251, V04153, V02650, V03417, V02935, V02185, V01432, V02150, V03456, V02782, V02194, V02078, V02127, V02217, V02810, V03748, V01533, V02957, V01864, V04385, V01632, V01633, V04318, V03008, V03011, V03047, V02492, V01135, V01161, V02602, V02934, V01482, V02186, V02884, V02411, V01200, V03245, V01627, V01877, V01094, V01092, V01303, V01332, V02962, V03090, V04341, V03977, V03953, V01876, V01147, V03797, V02809, V03467, V03700, V03775, V04335, V03357, V02180, V01376, V01978, V01981, V01985, V03438, V01486, V02460, V01642, V01616, V03427, V01502, V03889, V03105, V03106, V03107, V02269, V01713, V03384, V03716, V02808, V01620, V03858, V01649, V02295, V02306, V02468, V01059, V04372, V01645, V03441, V03376, V02874, V03145, V01375, V03853, V04242, V01919, V01236, V03187, V03698, V03825, V01389, V02398, V02129, V03382, V03055, V02195, V02201, V02097, V02093, V02085, V03470, V01326, V01237, V01505, V03920, V02018, V02706, V01834, V01400, V01401, V03573, V03836, V03388, V02656, V02674, V02414, V02314, V02456, V04311, V02861, V01641, V03402, V02419, V02558, V01243, V01244, V02239, V01973, V01612, V03474, V01442, V01388, V02429, V01294, V01298, V02069, V01159, V01393, V04279, V03383, V01730, V01046, V01274, V02717, V03958, V01078, V03957, V01117, V01118, V01752, V02517, V02587, V02868, V04313, V02920, V02965, V02964, V02130, V03439, V01534, V01664, V02505, V01250, V04375, V03576, V04382, V01770, V01377, V01431, V01072, V01862, V02317, V02287, V01134, V03186, V02367, V03796, V02453, V04236, V01977, V04256, V03114, V01360, V02881, V01553, V04391, V02796, V02958, V02852, V03819, V03827, V04278, V01309, V01948, V04248, V03423, V01314, V01076, V02992, V01893, V01889, V01361, V03434, V03419, V01459, V01915, V03133, V01437, V03463, V03481, V04193, V03163, V04345, V03335, V02875, V02193, V01871, V01755, V03046, V03978, V03086, V03089, V03088, V03087, V03085, V02988, V02983, V02995, V01599, V02756, V02123, V01625, V02568, V03444, V03444, V01929, V03859, V04353, V03143, V01149, V03372, V02067, V01184, V04097, V01610, V04401, V03864, V01329, V01281, V02697, V02727, V02065, V04367, V02509, V03849, V01132, V02054, V02033, V02036, V03560, V01540, V02849, V02724, V02646, V02665, V02462, V02020, V02021, V02966, V03318, V01551, V01989, V03356, V02529, V01313, V02956, V02952, V03860, V04117, V03793, V03794, V04137, V02110, V01788, V03303, V01170, V03254, V01765, V03274, V03275, V03316, V03331, V03278, V03201, V03043, V02669, V01213, V03813, V01570, V02190, V03440, V03082, V01874, V01210, V01462, V03918, V03786, V03422, V02144, V03057, V02337, V03415, V01990, V03370, V03391, V03915, V03250, V03281

MANUFACTURED & RECALLED BY Beckman Coulter Inc, Brea, CA

QUANTITY 1697 units

DISTRIBUTION Nationwide and internationally

REASON The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Femoral Driver

RECALL NUMBER To be determined


CODE Product number PE 93045101; lot number T16A178A, T16A178B, T16A178B1, T16A178C



MANUFACTURED & RECALLED BY United Orthopedic Corporation, Hsinchu, Taiwan

QUANTITY 33 units

DISTRIBUTION CA

REASON The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Premier Buffer B Reagent

RECALL NUMBER To be determined


CODE 01-03-0096, lot number 6506



MANUFACTURED & RECALLED BY Trinity Biotech, Jamestown, NY

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Difficulty in recovering beginning controls.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Advia Centaur® Systems, Progesterone, Immunoassay

RECALL NUMBER To be determined


CODE All


MANUFACTURED & RECALLED BY Siemens Healthcare Diagnostics, Inc, Tarrytown, NY

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON The presence of DHEA-S (a metabolite of DHEA, a steroid hormone that may be used as part of in vitro fertilization (IVF) protocols to improve ovarian response and IVF treatment outcomes) causes falsely elevated progesterone results.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Picture Archive Communication System (PACS)

RECALL NUMBER Z-1396-2017


CODE Model number 12.2



MANUFACTURED & RECALLED BY McKesson Medical Imaging, Richmond, Canada

QUANTITY 17

DISTRIBUTION AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT

REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Sonnet Mini Battery Pack

RECALL NUMBER Z-1395-2017


CODE Part number: 32291, Kit: 33372, Kit UDI: 09008737333720; Part number: 32292, Kit: 33374, Kit UDI: 09008737333744; Part number: 32293, Kit: 33375, Kit UDI: 09008737333751; Part number: 32294, Kit: 33376, Kit UDI: 09008737333768; Part number: 32295, Kit: 33377, Kit UDI: 09008737333775; Part number: 32296, Kit: 33378, Kit UDI: 09008737333782



MANUFACTURED & RECALLED BY MED-EL Elektromedizinische Gereate, Gmbh, Innsbruck, Austria

QUANTITY 538 units

DISTRIBUTION CA, NC, TX

REASON Units do not have the compartment lock firmly welded to the housing.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Left Double Lumen Endobronchial Tube with Parker Flex-Tip

RECALL NUMBER Z-1399-2017


CODE Model number H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1; lot number: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F



MANUFACTURED & RECALLED BY Parker Medical, Highlands Ranch, CO

QUANTITY 1,060 units

DISTRIBUTION CO, FL, IN, SC, TX, VA

REASON The product is not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Haemophilus Test Medium (Agar), 100mm & 150mm

RECALL NUMBER Z-1400-2017


CODE Reference number R01503, R04033; lot number 978596, 978948



MANUFACTURED & RECALLED BY Remel Inc, Lenexa, KS

QUANTITY 213

DISTRIBUTION Nationwide

REASON Test organisms exhibit poor growth when grown using the test agar.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT CaviWipes1 Extra Large

RECALL NUMBER Z-1402-2017


CODE Part number 13-5150, lot number 16-2340PA



MANUFACTURED & RECALLED BY Metrex Research, LLC, Romulus, MI

QUANTITY 960 cases

DISTRIBUTION PA, FL, IL, MN, TX, AL, NY

REASON Due to potentially being contaminated during the packaging process.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT K-Wires

RECALL NUMBER Z-1407-2017


CODE Part number 1600-9355NS, 1600-9625NS, 1604-162NS; lot number 61005, 60297, 62856



MANUFACTURED & RECALLED BY MicroAire Surgical Instruments, LLC, Charlottesville, VA

QUANTITY 362

DISTRIBUTION Nationwide

REASON Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Cardio software

RECALL NUMBER Z-1403-2017


CODE Version 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, 10.0



MANUFACTURED & RECALLED BY Merge Healthcare, Inc, Hartland, WI

QUANTITY 110 sites potentially have the affected versions

DISTRIBUTION Nationwide

REASON When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Contact lenses, color, labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear

RECALL NUMBER Z-1404-2017


CODE All lots of lenses sold between 10/31/2013 to 10/31/2016



MANUFACTURED & RECALLED BY The See Clear Company, Peachtree Corners GA

QUANTITY 119,829 units

DISTRIBUTION AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA, WA

REASON Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT 1) Premier Guard Sterile Drape for Use with Blair-Port Wand and Blair-Port Wand X

RECALL NUMBER Z-1408-2017

PRODUCT 2) Premier Guard Sterile Drape for Use with Verisphere and ArQ.Sphere

RECALL NUMBER Z-1409-2017


CODE 1) Item number: 01-0020; lot number: 1112351 to 1609891; 2) Item number: 01-0037; lot number: 14105774 to 1605778



MANUFACTURED & RECALLED BY Covidien LLC, North Haven, CT

QUANTITY 1,111,600 units

DISTRIBUTION Nationwide

REASON Sterility compromised due to breach in sterile barrier.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT UNI-CP System

RECALL NUMBER Z-1410-2017


CODE Model number: 330230SND, Lot number: FEDT



MANUFACTURED & RECALLED BY Integra LifeSciences Corp, Plainsboro, NJ

QUANTITY 39 units

DISTRIBUTION Nationwide

REASON Due to incorrect labeling.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT TotalCare® Bed System with 3-Level Patient Position Monitoring (PPM)

RECALL NUMBER Field correction


CODE Item number: P1900, PR1900, U1900, P1957A; Serial number: K328AM6065 to Q245AM0691, L082AL7316 to R343AL4516, L257AM0541 to O311AM7169



MANUFACTURED & RECALLED BY Hill-Rom, Inc, Batesville, IN

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Due to a potential issue with the bed exit alarm.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Knee, Hip and Nail Implants

RECALL NUMBER To be determined


CODE Item number:



00225236016

00225238016

00225240016

00225242016

00225244015

00225244016

00225246015

00225246016

00225248015

00225248016

00225250015

00225250016

00225344015

00225748004

00225748014

00225750004

00225750014

00585004620

00585004622

00585205217

00585205218

00585205219

00585205415

00585205416

00585205417

00585205418

00585205419

00585207419

00784301508

00784301608

00784301708

00784301808

00784302008

00992124033

00992125533


MANUFACTURED & RECALLED BY Zimmer Biomet, Inc, Warsaw, IN

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Due to packaging design verification test failures.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT External Catheter for Women-Wick

RECALL NUMBER To be determined

CODE Item number 625


MANUFACTURED & RECALLED BY Purewick Corporation, El Cajon, CA

QUANTITY 176,863 units

DISTRIBUTION Nationwide

REASON The labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the phrase "Latex-free."


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Triforce® Peripheral Crossing Set

RECALL NUMBER To be determined


CODE Catalog number kcfn-4.0-18-13-ra-hc, kcfn-4.0-18-23-ra-hc, kcfn-4.0-18-7--ra-hc, kcfn-5.0-18-13-ra-hc, kcfn-5.0-18-13-ra-s-hc, kcfn-5.0-18-23-ra-hc, kcfn-5.0-18-7-ra-hc, kcfn-6.0-18-13 ra-hc, kcfn-6.0-18-13-ra-s-hc, kcfn-6.0-18-23-ra-hc, kcfn-6.0-18-23-ra-s-hc, kcfn-6.0-18-7-ra-hc, kcfn-7.0-18-13-ra-hc, kcfn-7.0-18-23- ra- hc; lot number 6446175, 6532740, 6666826, 6893898, 6900003, 6751126, 7001937, 7025784, 7147504, 7167838, 7225192, 7341590, 7391310, 7504107, 6411880, 6446166, 6450116, 6519971, 6666769, 6908859, 6981926, 7001925, 7051610, 7022392, 7123268, 7147499, 7184449, 7267450, NS7332359, 7358081, 7403790, 7496485, 6322996, 6446178, 6446181, 6462180, 6886608, 7019961, 7031499, 7164021, 7184452, 7267458, 7332311, 7444323, 6212456, 6351788, 6446172, 6446169, 6450119, 6662625, 6822810, 6939576, 7001928, 7016608, 7034665, NS7092904, 7140948, 7177780, 7242814, 7370525, 7399858, 6431150, 6446148, 6496311, 6439404, 6465775, 6468502, 6505550, 6555370, 6446151, 6758994, 6920504, 6988935, 7025708, 7130536, 7193377, 7235257, 7315111, 7235257X, 7464305, 7546373, 6446157, 6446160, 6446163, 6496304, 6886566, 6751104, 6998644, 7025749, 7164024, 7228339, 7288208, 7428802, NS7464569, 7507654, 6434689, 6458182, 6458188, 6458185, 6465778, 6496301, 6666717, 6805492, 6458185X, 6539377, 6751089, 6946858, 7003999, 7045070, 7100478, NS7092907, 7140908, 7225167, 7315130, NS7344637, 7496421, 6431153, 6434671, 6493096, 6446154, 6496292, 6781963, 6908811, 7019894, 7048460, 7147489, 7157893, 7225152, 7319336, 7444262



MANUFACTURED & RECALLED BY Cook Medical, Inc, Bloomington, IN

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON This is an update to recall number Z-1393-2017 posted on 2/7/17 to include additional lot numbers. Due to increased reports of blood loss associated with devices using a specific hemostatic valve design (referred to as the “blue” valve or polyisoprene valve).


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT ProBP 2400 Digital NIBP Device

RECALL NUMBER To be determined


CODE Lot number 0715001 to 07150620, 12150001 to 12150500



MANUFACTURED BY Microlife USA, Inc, Clearwater, FL

RECALLED BY Welch Allyn, Skaneateles Falls, NY

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON A potential over-voltage battery charging condition causing the plastic to melt.
----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT RIO THA Application User Guides, for total hip arthroplasty

RECALL NUMBER Z-1411-2017


CODE Item number: 204863, 207116, 208692, 209711, 210555, 212026



MANUFACTURED & RECALLED BY Mako Surgical Corporation, Davie, FL

QUANTITY 777

DISTRIBUTION Nationwide

REASON Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Covidien Curity™ eye pad, Curity™ eye pad oval, Kerlix™ super sponge saline dressing, Curity™ wet dressing, Curity™ sodium chloride dressing and Curity™ saline dressing

RECALL NUMBER To be determined

CODE Item number: 03201, 2841, 91650; lot number: beginning with 12,13,14,15,16; Item number: 3337, 3338, 3339, 3606; lot number: beginning with 14,15,16; lot number: exclude 16J098062, 16J098162, 16J098262


MANUFACTURED & RECALLED BY Medtronic, North Haven, CT

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Due to the potential for the sterile packaging to be compromised.

ACTION Quarantine and return the affected lots. With questions call Customer Service at 800-882-5878 or contact your Medtronic representative.
----------------------------------------------------------------------------------------------------------------------------------------------
THE FOLLOWING IS A CLASS I RECALL. THERE IS A REASONABLE PROBABILITY THAT THE USE OF THE AFFECTED PRODUCT MAY CAUSE SERIOUS INJURY OR DEATH IF THE PROBLEM IS NOT CORRECTED.
PRODUCT Eye Wash, 4 fl oz, 118 mL bottle, OTC

RECALL NUMBER D-0496-2017


CODE NDC 0904-6491-20; lot number G15905, G15907



MANUFACTURED & RECALLED BY United Exchange Corporation, Cerritos, CA

QUANTITY 46,080 bottles

DISTRIBUTION Nationwide

REASON Direct evidence of contamination for two lots based on FDA samples.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT 1) Eye Irrigating Solution, 4 fl oz, 118 mL bottle, OTC

RECALL NUMBER D-0497-2017

PRODUCT 2) Eye Wash, 4 fl oz, 118 mL bottle, OTC

RECALL NUMBER D-0498-2017

PRODUCT 3) Eye Wash, 4 fl oz, 118 mL bottle, OTC

RECALL NUMBER D-0499-2017


CODE 1) NDC 0536-1083-97; lot number G15908, G15909, G16904, G16908, G16912, G16913; 2) UPC 780707005828; lot number G15901, G15902, G15903, G15904, G16909; 3) NDC 0904-6491-20; lot number G15906, G15910, G15911, G15912, G16901, G16902, G16903, G16905, G16906, G16907, G16910, G16911



MANUFACTURED & RECALLED BY United Exchange Corporation, Cerritos, CA

QUANTITY 1) 112,320 bottles; 2) 77,184 bottles; 3) 190,710 bottles

DISTRIBUTION Nationwide

REASON Lack of assurance of sterility.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT 1) glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only

RECALL NUMBER D-0491-2017

PRODUCT 2) Mirtazapine Tablets, USP, 45 mg, 30 count, 100 count and 500 count

RECALL NUMBER D-0492-2017

PRODUCT 3) Mirtazapine Tablets, USP, 45 mg, Rx only, 100 Tablets (10 X 10)

RECALL NUMBER D-0493-2017


CODE 1) NDC 0378-0342-10; batch number:3074621; 2) NDC 0378-3545-93, 0378-3545-01, 0378-3545-05; batch number 3078937, 3078938, 3078936; 3) batch number 3083289



MANUFACTURED & RECALLED BY Mylan Pharmaceuticals Inc, Morgantown, WV

QUANTITY 1) 1,338 bottles; 2) 37,445 bottles; 3) 58 Blister Cards of 10

DISTRIBUTION Nationwide

REASON Presence of foreign tablets/capsules in the bottles.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT DESONIDE OIN 0.05% 60GM

RECALL NUMBER To be determined

CODE NDC 00168030960; lot number GC9231, GC9232


MANUFACTURED & RECALLED BY Fougera Pharmaceuticals Inc, Melville, NY

QUANTITY Not available at publication

DISTRIBUTION Nationwide

REASON Due to a packaging mix-up.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only

RECALL NUMBER D-0495-2017

CODE NDC 0074-3012-07; lot number 1055692, 1057881, 1060138, 1060140, 1061258, 1061262, 1063033


MANUFACTURED & RECALLED BY AbbVie Inc, North Chicago, IL

QUANTITY 4021 cartons, 7 100-mL cassettes each

DISTRIBUTION TN, IL

REASON Failed stability specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT 1) Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only

RECALL NUMBER D-0503-2017

PRODUCT 2) Salicylic Acid Cream, 6%, 400g bottle, Rx Only

RECALL NUMBER D-0504-2017

CODE 1) NDC 45802-237-01; lot number 099534, 099512; 2) NDC 45802-806-01; lot number 098840, 098779

MANUFACTURED & RECALLED BY L Perrigo Company, Allegan, MI

QUANTITY 10,656 units total for both products

DISTRIBUTION Nationwide

REASON Failed impurities/degradation specifications: the API for these products had an out of specification result for an organic impurity.
----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only

RECALL NUMBER D-0490-2017

CODE NDC 68084-921-25, lot number 154527


MANUFACTURED & RECALLED BY Amerisource Health Services, Columbus, OH

QUANTITY 454 cartons

DISTRIBUTION Nationwide

REASON Failed impurities/degradations specifications: out of specification results for Maximum Unknown Impurities and Total Impurities.


----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT HealthA2Z Chewable Aspirin (NSAID) 81 mg, Orange Flavor, 36 Tablets, OTC

RECALL NUMBER D-0500-2017

CODE 369168288362 (FP0545), (6K28817); lot number 6K28817

MANUFACTURED & RECALLED BY Allegiant Health, Deer Park, NY

QUANTITY 70,176 bottles; 9,000,000 tablets (bulk)

DISTRIBUTION Nationwide

REASON CGMP deviations - presence of rubber particles found loose in the bulk product.
----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only

RECALL NUMBER D-0502-2017

CODE NDC 47335-956-88; lot number JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A


MANUFACTURED & RECALLED BY Sun Pharmaceutical Industries, Inc, Cranbury, NJ

QUANTITY 22,915 bottles

DISTRIBUTION Nationwide

REASON Presence of foreign substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.


----------------------------------------------------------------------------------------------------------------------------------------------





The database is protected by copyright ©dentisty.org 2016
send message

    Main page