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NRAC Issue #2111 July 20, 2016 15 Pages
NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION
THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION
THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC
SUMMARY PAGE
MEDICAL DEVICES
PRODUCT AccuCath Intravascular Catheters
MANUFACTURER Bard Access Systems, Inc
PAGE 4
PRODUCT Allura Xper R8.2 and UNIQ R1.0 X-ray Systems
MANUFACTURER Philips Healthcare
PAGE 5
PRODUCT Angiographic Injector and Syringe, etc
MANUFACTURER Bayer Healthcare
PAGE 12
PRODUCT Angio WorkStation
MANUFACTURER Toshiba American Medical Systems Inc
PAGE 7
PRODUCT Brand Conforming Stretch Gauze Bandages
MANUFACTURER Amd-Ritmed, Inc
PAGE 6
PRODUCT Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)
MANUFACTURER CSL Behring GmbH
PAGE 12
PRODUCT ENDOPATH® ETS-FLEX Endoscopic Articulating Linear Cutter, 35mm
MANUFACTURER Ethicon Endo-Surgery, Inc
PAGE 6
PRODUCT Goldstein Flexi Thin Composite Instrument, #3
MANUFACTURER Hu-Friedy Mfg Co, LLC
PAGE 5
PRODUCT HemaPrompt FG test cards
MANUFACTURER Aerscher Diagnostics
PAGE 4
PRODUCT Liat Influenza A/B Quality Control Kit
MANUFACTURER Bard Access Systems, Inc
PAGE 4
PRODUCT Mammotome Revolve Dual Vacuum Assist Biopsy System
MANUFACTURER Devicor Medical Products Inc
PAGE 4
PRODUCT Metal on Metal Total Hip Arthroplasty (THA) component families
MANUFACTURER MicroPort Orthopedics Inc
PAGE 3
PRODUCT Modified Linear Standard/Lateral Neck Trails with Spring Sides
MANUFACTURER Encore Medical, LP
PAGE 12
PRODUCT RayStation therapy treatment planning system stand-alone software
MANUFACTURER RaySearch Laboratories AB
PAGE 6
PRODUCT Replace Select Tapered TiU NP 3.5x11.5mm
MANUFACTURER Nobel Biocare USA LLC
PAGE 14
PRODUCT Round Fluted Bur, Super Long
MANUFACTURER Stryker Instruments Div of Stryker Corporation
PAGE 5
PRODUCT Spike Set 12" Microbore SPM-12, etc
MANUFACTURER WalkMed Infusion, LLC
PAGE 9
PRODUCT Spirit Plus and Spirit Select Hospital Beds
MANUFACTURER Stryker Medical Division of Stryker Corporation
PAGE 11
PRODUCT Suction Canister with Lid 490 cc
MANUFACTURER Hologic, Inc
PAGE 11
PRODUCT Tapered Router, 2.3MM
MANUFACTURER Stryker Instruments Div of Stryker Corporation
PAGE 11
PRODUCT Temperature Management System, HX2”, etc
MANUFACTURER Terumo Cardiovascular Systems Corporation
PAGE 5
PRODUCT Trach-Vac Endotracheal Tubes
MANUFACTURER Parker Medical
PAGE 11
PRODUCT Triton Infusion Pump, etc
MANUFACTURER WalkMed Infusion, LLC
PAGE 7
PRODUCT Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve
MANUFACTURER Synthes (USA) Products LLC
PAGE 6
PRODUCT TSP Hip Fracture Plating System
MANUFACTURER Biomet, Inc
PAGE 12
PRODUCT TWINFIX QUICK-T Knot Pusher Suture Cutter
MANUFACTURER Smith & Nephew, Inc
PAGE 7
PRODUCT UniCel DxC Synchron Systems No Foam Reagent
MANUFACTURER Beckman Coulter Inc
PAGE 3
PHARMACEUTICALS
PRODUCT Dextroamphetamine sulfate
MANUFACTURER Actavis Pharma, Inc
PAGE 15
PRODUCT Diazepam Injection
MANUFACTURER Hospira Inc
PAGE 14
PRODUCT Duloxetine Delayed-release Capsules 60 mg Gold 1000
MANUFACTURER Golden State Medical Supply, Inc
PAGE 14
PRODUCT NV Quattro Air & Quattro Air Mask
MANUFACTURER ResMed
PAGE 14
PRODUCT Oxycodone HCl, Oral Solution USP
MANUFACTURER Boehringer Ingelheim Roxane, Inc
PAGE 14
PRODUCT Ruby®’s Diocto Liquid
MANUFACTURER Supernus Pharmaceuticals, Inc
PAGE 15
PRODUCT Trokendi XR 50 mg Capsules
MANUFACTURER Supernus Pharmaceuticals, Inc
PAGE 15
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PRODUCT UniCel DxC Synchron Systems No Foam Reagent
RECALL NUMBER Field correction
CODE REF B64130
MANUFACTURED & RECALLED BY Beckman Coulter Inc, Brea, CA
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON An incompatibility between No Foam DxC reagent and the DxC hydropheumatic parts associated with No Foam delivery. No Foam reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the hydropheumatic subsystems.
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PRODUCT Metal on Metal Total Hip Arthroplasty (THA) component families: CONSERVE Shell, DYNASTY Metal Liner, PROCOTYL Metal Liner, LINEAGE Metal Liner
RECALL NUMBER Field correction
CODE All units
MANUFACTURED & RECALLED BY MicroPort Orthopedics Inc, Arlington, TN
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Investigation of the Metal on Metal THA systems shows an increasing overall trend in revisions from 2009 to present, and it was found that there was a specific hazard/harm for “suspected tissue reaction to metal debris”. The potential for a patient reaction when implanted with Metal on Metal THA is a known risk for this product technology. The instructions for use have been updated due to the voluntary recall of Metal on Metal THA component families for this specific indication.
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PRODUCT HemaPrompt FG test cards
RECALL NUMBER To be determined
CODE Lot number 963, 965, 967, 969
MANUFACTURED & RECALLED BY Aerscher Diagnostics, Chestertown, MD
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Reports of internal control failure due to insufficient developer on the card (dry cards).
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PRODUCT Mammotome Revolve Dual Vacuum Assist Biopsy System
RECALL NUMBER Z-2211-2016
CODE MST1009 – lot F11537107D1, F11537109D1; MST0815 – lot F11536423D1
MANUFACTURED & RECALLED BY Devicor Medical Products Inc, Cincinnati, OH
QUANTITY F11537107D1 = 360, F11536423D1 = 80, F11537109D1 = 360
DISTRIBUTION AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA, WI
REASON A 10 Gauge needle, 9cm long, was shipped in an 8 Gauge needle, 15 cm package.
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PRODUCT Liat Influenza A/B Quality Control Kit
RECALL NUMBER Z-2203-2016
CODE Lot number 51222E, 60121H, 60201D, 60229F
MANUFACTURED & RECALLED BY Roche Molecular Systems, Inc, Branchburg, NJ
QUANTITY 194 distributed kits
DISTRIBUTION TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, LA
REASON Kit labeled with the incorrect expiration date.
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PRODUCT AccuCath Intravascular Catheters, 18G, 1.25 in and 2.25 in
RECALL NUMBER To be determined
CODE Product code VP12518BC, VP22518BC; lot number 730134, 736693, 736694, 683967, 017639, 724927
MANUFACTURED & RECALLED BY Bard Access Systems, Inc, Salt Lake City, UT
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Some 18G AccuCath Intravascular Catheters could have catheter shafts that are in the 17G range.
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PRODUCT Goldstein Flexi Thin Composite Instrument, #3
RECALL NUMBER To be determined
CODE Product code: TNCIGFT3, CIGFT3, CIGFT36, CIGFT38; kit number: E4DRKIT, IMCOMPOSIQ, IMCOMPOSIT, IMNCMPOSIT, IMNRESTOR, IMRESTOR, IMRESTORQ, TNANTKIT, TNCIGFT3, CIGFTSET
MANUFACTURED & RECALLED BY Hu-Friedy Mfg Co, LLC, Chicago, IL
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Hu-Friedy has determined that a limited number of the instrument pattern displays an increased risk of brakeage.
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PRODUCT Allura Xper R8.2 and UNIQ R1.0 X-ray Systems
RECALL NUMBER Field correction
CODE Product code: Allura Xper – 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059; UNIQ – 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059
MANUFACTURED & RECALLED BY Philips Healthcare, Andover, MA
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Philips Healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage DC power supplies (DCPS) used in these products.
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PRODUCT 1) Temperature Management System, HX2”
RECALL NUMBER Z-2207-2016
PRODUCT 2) Sarns TCM
RECALL NUMBER Z-2208-2016
PRODUCT 3) Sarns TCM II
RECALL NUMBER Z-2209-2016
PRODUCT 4) Preamendments Device - Sarns Dual Cooler-Heater
RECALL NUMBER Z-2210-2016
CODE Catalog number: 1) 809810; 2) 15747; 3) 4416, 164925, 164930, 164935, 164940; 4) 11160, 4332, 14114, 13460
MANUFACTURED & RECALLED BY Terumo Cardiovascular Systems Corporation, Ann Arbor, MI
QUANTITY 6412 units
DISTRIBUTION Nationwide and internationally
REASON Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
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PRODUCT 1) Round Fluted Bur, Super Long, 5.0mm
RECALL NUMBER Z-2204-2016
PRODUCT 2) Round Fluted Bur, Super Long, 6.0mm
RECALL NUMBER Z-2205-2016
CODE 1) Product code 5190-010-050; lot number 15322017; 2) product code 5190-010-060; lot number 15231017, 16033017, 16066017
MANUFACTURED & RECALLED BY Stryker Instruments Div of Stryker Corporation, Portage, MI
QUANTITY 25
DISTRIBUTION CA, IL, SD
REASON Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion, which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
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PRODUCT Brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds/15 cm x 3.7 cm
RECALL NUMBER Z-2213-2016
CODE Product code: D606, bar code: 6 86864 04230 3, lot number: 64155
MANUFACTURED & RECALLED BY Amd-Ritmed, Inc, Tonawanda, NY
QUANTITY 107 cases (48 rolls per case)
DISTRIBUTION NY, CA, TN
REASON The product lot did not meet sterility requirements based on FDA sampling and analysis.
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PRODUCT RayStation therapy treatment planning system stand-alone software 3.0, 3.5, 4.0, 4.5, 4.7, 5.0
RECALL NUMBER Z-2206-2016
CODE Versions: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35
MANUFACTURED & RECALLED BY RaySearch Laboratories AB, Stockholm, Sweden
QUANTITY 170 units
DISTRIBUTION CA, CT, DE, FL, HI, ME, MO, NY, OH, TX, WA
REASON An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents, however, the user must be aware of this information to avoid incorrect plan evaluation during treatment planning.
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PRODUCT Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve
RECALL NUMBER Z-2214-2016
CODE Part number: 03.037.017; lot number: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306
MANUFACTURED & RECALLED BY Synthes (USA) Products LLC, West Chester, PA
QUANTITY 2,064 units
DISTRIBUTION Nationwide
REASON DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part #03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.
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PRODUCT ENDOPATH® ETS-FLEX Endoscopic Articulating Linear Cutter, 35mm
RECALL NUMBER To be determined
CODE Product code: ATW35, ATB35; lot number: N91L0U, N91N1K, N91N29, N91L48, N91R40
MANUFACTURED & RECALLED BY Ethicon Endo-Surgery, Inc, Cincinnati, OH
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON There is a risk that the pinion gear in the device could fail under extreme use cases.
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PRODUCT TWINFIX QUICK-T Knot Pusher Suture Cutter
RECALL NUMBER Z-2218-2016
CODE Part Number 7209417, batch numbers 50412843, 50477278, 50527184
MANUFACTURED & RECALLED BY Smith & Nephew, Inc, Mansfield, MA
QUANTITY 563
DISTRIBUTION Nationwide and internationally
REASON The device could be subject to breaches of its sterile packaging.
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PRODUCT Angio WorkStation
RECALL NUMBER Z-2188-2016
CODE Model Number XIDF-AWS801; v6.00, v6.01, v6.10; INFX-8000V Bi-Plane System
MANUFACTURED & RECALLED BY Toshiba American Medical Systems Inc, Tustin, CA
QUANTITY 23
DISTRIBUTION NC, NY, TX, GA, CA, AZ, IL, FL, MA, MO, DE
REASON During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
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PRODUCT 1) Triton Infusion Pump
RECALL NUMBER Z-2219-2016
PRODUCT 2) Triton FP Infusion Pump
RECALL NUMBER Z-2220-2016
CODE 1) Model number 300000; product code: TR1041, TR1043, TR1044, TR1047, TR1049, TR1051, TR1053, TR1054, TR1055, TR1056, TR1058, TR1059, TR1060, TR1061, TR1062, TR1063, TR1064, TR1065, TR1066, TR1067, TR1068, TR1069, TR1070, TR1071, TR1072, TR1073, TR1074, TR1077, TR1078, TR1079, TR1080, TR1081, TR1082, TR1083, TR1084, TR1085, TR1086, TR1087, TR1088, TR1089, TR1090, TR1091, TR1093, TR1094, TR1095, TR1096, TR1097, TR1099, TR1100, TR1101, TR1102, TR1105, TR1106, TR1107, TR1109, TR1110, TR1111, TR1113, TR1114, TR1115, TR1116, TR1117, TR1118, TR1120, TR1121, TR1122, TR1123, TR1124, TR1125, TR1126, TR1127, TR1128, TR1129R, TR1131, TR1132, TR1133, TR1134, TR1136, TR1137, TR1138, TR1141, TR1142, TR1143, TR1144, TR1145, TR1146, TR1147, TR1148, TR1149, TR1150, TR1151, TR1154, TR1156, TR1157, TR1158, TR1159, TR1160, TR1161, TR1163, TR1164, TR1165, TR1166, TR1167, TR1168, TR1169, TR1170, TR1171, TR1172, TR1173, TR1174, TR1175, TR1176, TR1177, TR1178, TR1179, TR1180, TR1182, TR1183, TR1184, TR1185, TR1186, TR1187, TR1190, TR1191, TR1192, TR1193, TR1194, TR1195, TR1197, TR1198, TR1200, TR1201, TR1202, TR1203, TR1204, TR1205, TR1206, TR1207, TR1208, TR1209, TR1210, TR1211, TR1212, TR1213, TR1216, TR1218, TR1219, TR1220, TR1222, TR1223, TR1224, TR1226, TR1227, TR1228, TR1229, TR1230, TR1234, TR1235, TR1236, TR1238, TR1239, TR1240, TR1241, TR1243, TR1246, TR1247, TR1248, TR1249, TR1250, TR1251, TR1252, TR1252R, TR1253, TR1254, TR1255, TR1256, TR1257, TR1258, TR1261, TR1263, TR1264, TR1266, TR1269, TR1270, TR1271, TR1272, TR1273, TR1274, TR1275, TR1276, TR1277, TR1278, TR1279, TR1280, TR1281, TR1282, TR1283, TR1284, TR1285, TR1286, TR1287, TR1288, TR1289, TR1290, TR1291, TR1292, TR1293, TR1294, TR1295, TR1296, TR1297, TR1298, TR1299, TR1300, TR1301, TR1302, TR1303, TR1304, TR1305, TR1306, TR1307, TR1308, TR1309, TR1310, TR1311, TR1312, TR1313, TR1314, TR1315, TR1317, TR1318, TR1319, TR1320, TR1321R, TR1322, TR1323, TR1324, TR1325, TR1326, TR1327, TR1328, TR1329, TR1330, TR1332, TR1335, TR1336, TR1339, TR1341, TR1342, TR1344R, TR1346, TR1347, TR1348, TR1349, TR1351, TR1352, TR1353, TR1354, TR1355, TR1356, TR1358, TR1359, TR1360, TR1361, TR1363, TR1364, TR1365, TR1366, TR1367, TR1368, TR1370, TR1371, TR1372, TR1373, TR1375, TR1377, TR1378, TR1379, TR1380, TR1381, TR1383, R1384R, TR1385, TR1387, TR1388, TR1389, TR1390, TR1391, TR1392, TR1393, TR1394, TR1395, TR1396, TR1399, TR1400, TR1401, TR1403, TR1407, TR1409, TR1411, TR1412, TR1413, TR1414, TR1415, TR1417, TR1418, TR1419, TR1420, TR1421, TR1422, TR1423, TR1424, TR1425, TR1426, TR1427, TR1428, TR1429, TR1430, TR1432, TR1433, TR1436, TR1437, TR1439, TR1440, TR1443, TR1444, TR1445, TR1446, TR1447, TR1449, TR1450, TR1451, TR1452, TR1453, TR1454, TR1455, TR1456, TR1457, TR1458, TR1459, TR1462, TR1463, TR1465, TR1466, TR1467, TR1468, TR1470, TR1471, TR1472, TR1474, TR1475, TR1476, TR1477, TR1478, TR1480, TR1481, TR1482, TR1483, TR1486, TR1487, TR1488, TR1489, TR1490, TR1491, TR1493, TR1496, TR1497, TR1498, TR1499, TR1500, TR1502, TR1504, TR1505, TR1506, TR1508, TR1509, TR1510, TR1511, TR1512, TR1515, TR1516, TR1520, TR1521, TR1522, TR1524, TR1527, TR1529, TR1531, TR1532, TR1535, TR1536, TR1537, TR1538, R1539R, R1540R, TR1545, TR1546, TR1547, TR1548, TR1549, TR1550, TR1551, TR1554, TR1555, TR1556, TR1558, TR1559, TR1560, TR1562, TR1563, TR1564, TR1566, TR1567, TR1568, TR1571, TR1572, TR1573, TR1574, TR1575, TR1576, TR1577, TR1579, TR1580, TR1581, TR1582, TR1584, TR1587, TR1588, TR1589, TR1590, TR1592, TR1593, TR1594, TR1595, TR1597, TR1598, TR1599, TR1600, TR1601, TR1602, TR1603, TR1606, TR1607, TR1608, TR1612, TR1613, TR1614, TR1617, TR1618, TR1620, TR1622, TR1625, TR1627, TR1630, TR1631, TR1634, TR1635, TR1636, TR1637, TR1640, TR1642, TR1643, TR1645, TR1646, TR1647, TR1650, TR1651, TR1653, TR1654, TR1656, TR1657, TR1660, TR1661, TR1663, TR1664, TR1665, TR1666, TR1668, TR1670, TR1671, TR1672, TR1673, TR1674, TR1677, TR1679, TR1680, TR1681, TR1682, TR1683, TR1684, TR1685, TR1687, TR1689, TR1691, TR1692, TR1694, TR1695, TR1697, TR1698, TR16; 2) Model number 400000; product code: PCF15045R, PFA13002, PFA13005, PFA13006, PFA13007, PFA13008, PFA13009, PFA13010, PFA13011, PFA13012, PFA13013, PFA13014, PFA13015, PFA13016, PFA13017, PFA13018, PFA13019, PFA13020, PFA13021, PFA13022, PFA13023, PFA13024, PFA13025, PFA13026, PFA13027, PFA13028, PFA13029, PFA13030, PFA13031, PFA13032, PFA13033, PFA13034, PFA13035, PFA13036, PFA13037, PFA13038, PFA13039, PFA13040, PFA13041, PFA13042, PFA13043, PFA13044, PFA13045, PFA13046, PFA13047, PFA13048, PFA13049, PFA13050, PFA14001, PFA14002, PFA14003, PFA14004, PFA14005, PFA14006, PFA14007, PFA14008, PFA14009, PFA14010, PFA14011, PFA14012, PFA14013, PFA14014, PFA14015, PFA14016, PFA14017, PFA14018, PFA14019, PFA14020, PFA14021, PFA14022, PFA14023, PFA14024, PFA14025, PFA14026, PFA14027, PFA14028, PFA14029, PFA14030, PFA14031, PFA14032, PFA14034, PFA14035, PFA14036, PFA14037, PFA14038, PFA14039, PFA14040, PFA14041, PFA14042, PFA14043, PFA14044, PFA14045, PFA14046, PFA14047, PFA14048, PFA14049, PFA14050, PFA14051, PFA14052, PFA14053, PFA14054, PFA14055, PFA14056, PFA14057, PFA14058, PFA14059, PFA14060, PFA15001, PFA15002, PFA15003, PFA15004, PFA15005, PFA15006, PFA15007, PFA15008, PFA15009, PFA15010, PFA15011, PFA15012, PFA15013, PFA15014, PFA15015, PFA15016, PFA15017, PFA15018, PFA15019, PFA15020, PFA15021, PFA15022, PFA15023, PFA15024, PFA15025, PFA15026, PFA15027R, PFA15028, PFA15029, PFA15030, PFA15031, PFA15032, PFA15033, PFA15035, PFA15036, PFA15037, PFA15038, PFA15039, PFA15041, PFA15043, PFA15044, PFA15045, PFA15046, PFA15047, PFA15050R, PFA15051, PFA15052, PFA15053, PFA15054, PFA15055, PFA15056, PFA15057, PFA15058, PFA15059, PFA15060, PFA15061, PFA15062, PFA15063, PFA15064, PFA15065, PFA15066, PFA15067, PFA15068, PFA15069, PFA15070, PFA15071, PFA15072, PFA15073, PFA15074, PFA15075, PFA15076, PFA15077, PFA15078, PFA15079, PFA15080, PFA15081, PFA15082, PFA15083, PFA15084, PFA15085, PFA15086, PFA15087, PFA15088, PFA15089, PFA15090, PFA15091, PFA15092, PFA15093, PFA15094, PFA15095, PFA15096, PFA15097, PFA15098, PFA15099, PFA15100, PFB13001, PFB13002, PFB13003, PFB13004, PFB13005, PFB13006, PFB13007, PFB13008, PFB13009, PFB13010, PFB13011, PFB13012, PFB13013, PFB13014, PFB13015, PFB13016, PFB13017, PFB13018, PFB13019, PFB13020, PFB13021, PFB13022, PFB13023, PFB13024, PFB13025, PFB13026, PFB13027, PFB13028, PFB13029, PFB13030, PFB13031, PFB13032, PFB13033, PFB13034, PFB13035, PFB13036, PFB13037, PFB13038, PFB13039, PFB13040, PFB13041, PFB13042, PFB13043, PFB13044, PFB13045, PFB13046, PFB13047, PFB13048, PFB13049, PFB13050, PFB15001, PFB15002, PFB15003, PFB15004, PFB15005, PFB15006, PFB15007, PFB15008, PFB15009, PFB15010, PFB15011, PFB15012, PFB15013, PFB15014, PFB15015, PFB15016, PFB15017, PFB15018, PFB15019, PFB15020, PFB15021, PFB15022, PFB15023, PFB15024, PFB15025, PFB15026, PFB15027, PFB15028, PFB15029, PFB15030, PFB15031, PFB15032, PFB15033, PFB15034, PFB15035, PFB15036, PFB15037, PFB15038, PFB15039, PFB15040, PFB15041, PFB15042, PFB15043, PFB15044, PFB15045, PFB15046, PFB15047, PFB15048, PFB15049, PFB15050, PFB15051, PFB15052, PFB15053, PFB15054, PFB15055, PFB15056, PFB15057, PFB15058, PFB15059, PFB15060, PFB15061, PFB15065R, PFB15066, PFB15068, PFB15069, PFB15070, PFB15071, PFB15072, PFB15073, PFB15074, PFB15075, PFB15076, PFB15077, PFB15078, PFB15079, PFB15080, PFB15081, PFB15082, PFB15083, PFB15084, PFB15085, PFB15086, PFB15087, PFB15088, PFB15089, PFB15090, PFB15091, PFB15092, PFB15093, PFB15094R, PFB15095, PFB16001, PFB16002, PFB16003, PFB16004, PFB16005, PFB16006, PFB16007, PFB16008, PFB16009, PFB16010, PFB16011, PFB16012, PFB16013, PFB16014, PFB16015, PFB16016, PFB16017, PFB16018, PFB16019, PFB16020, PFB16021, PFB16022, PFB16023, PFB16024, PFB16025, PFB16026, PFB16027, PFB16028, PFB16029, PFB16030, PFB16031, PFB16032, PFB16033, PFB16034, PFB16035, PFB16036, PFB16037, PFB16038, PFB16039, PFB16040, PFB16041, PFB16042, PFB16043, PFB16044, PFB16045, PFB16046, PFB16047, PFB16048, PFB16049, PFB16050, PFB16051, PFB16052, PFB16053, PFB16054, PFB16055, PFB16056, PFB16
MANUFACTURED & RECALLED BY WalkMed Infusion, LLC, Englewood, CO
QUANTITY 1) 2482 units, 2) 2966 units
DISTRIBUTION AL, AZ, CA, FL, IL, KS, MA, MD, MS, NJ, OH, PA, TN, TX, UT, WA
REASON Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
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PRODUCT 1) Spike Set 12" Microbore SPM-12
RECALL NUMBER Z-2221-2016
PRODUCT 2) T030-000 30" 20 Drop IV Admin Secondary Set
RECALL NUMBER Z-2222-2016
PRODUCT 3) T090-000 90" 20 Drop IV Admin Set
RECALL NUMBER Z-2223-2016
PRODUCT 4) T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site
RECALL NUMBER Z-2224-2016
PRODUCT 5) T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve
RECALL NUMBER Z-2225-2016
PRODUCT 6) T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr
RECALL NUMBER Z-2226-2016
PRODUCT 7) T095-022 IV Set with 0.22 Micron Filter
RECALL NUMBER Z-2227-2016
PRODUCT 8) T095-120 IV Set with 1.2 Micron Filter
RECALL NUMBER Z-2228-2016
PRODUCT 9) T100-000F 100" IV Set with Free Flow Clip
RECALL NUMBER Z-2229-2016
PRODUCT 10) T100-000VF IV Set with Lower Y Site and Free Flow Clip
RECALL NUMBER Z-2230-2016
PRODUCT 11) T100-000WF IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip
RECALL NUMBER Z-2231-2016
PRODUCT 12) T100-022F with 0.22 micron filter and FP Clip
RECALL NUMBER Z-2232-2016
PRODUCT 13) T100-120F with 1.2 micron filter and FP Clip
RECALL NUMBER Z-2233-2016
PRODUCT 14) T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap
RECALL NUMBER Z-2234-2016
PRODUCT 15) T100-022WF IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip
RECALL NUMBER Z-2235-2016
CODE 1) Product number: 020-204840; Lot number: 1504031D; 2) Product number: 020-300188; Lot number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D; 3) Product number: 020-300197l; Lot number: 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, 1507012D; 4) Product number: 020-300198; Lot number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D; 5) Product number: 020-300204; Lot number: 1406006, 1406008, 1406170, 1406171, 1406172, 1406173, 1406174, 1407125, 1407126, 1407127, 1407128, 1407129, 1408076, 1408077, 1409038D, 1409039D, 1409040D, 1410074D, 1410075D, 1410076D, 1410077D, 1411066D, 1411067D, 1412003D, 1412004D, 1412006D, 1412007D, 1501054D, 1501055D, 1501056D, 1501057D, 1501058D, 1502023D, 1502025D, 1502033D, 1503051D, 1503053D, 1506055D, 1506057D; 6) Product number: 020-300206; Lot number: 1406087, 1407505, 1409132D, 1409133D, 1412060D, 1503090D; 7) Product number: 020-300576; Lot number: 1407016, 1410164D, 1411070D, 1501024D, 1503091D, 1506091D; 8) Product number: 020-300577; Lot number: 1407025; 9) Product number: 020-300642; Lot number: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, 1508008D; 10) Product number: 020-300643; Lot number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D; 11) Product number: 020-300644; Lot number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D; 12) Product number: 020-300649; Lot number: 1412061D, 1503069D, 1505046D, 1506087D; 13) Product number: 020-300650; Lot number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D; 14) Product number: 020-300692; Lot number: 1407023, 1409042D, 1410166D, 1411072D, 1412062D; 15) Product number: 020-300828; Lot number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134
MANUFACTURED & RECALLED BY WalkMed Infusion, LLC, Englewood, CO
QUANTITY 1) 37 cases, 2) 2453 cases, 3) 2757 cases, 4) 3342 cases, 5) 7529 cases, 6) 679 cases, 7) 304 cases, 8) 58 cases, 9) 1323 cases, 10) 1857 cases, 11) 2198 cases, 12) 383 cases, 13) 295 cases, 14) 270 cases, 15) 1147 cases
DISTRIBUTION AL, AZ, CA, FL, IL, KS, MA, MD, MS, NJ, OH, PA, TN, TX, UT, WA
REASON Due to the Potential Presence of Particulate In or On the Administration Sets.
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PRODUCT Spirit Plus and Spirit Select Hospital Beds
RECALL NUMBER To be determined
CODE Model number: 5600, 5700; serial number: 035542, 035543, 035544, 035545, 035546, 035547, 035548, 035549, 035550, 035551, 035552, 035553, 035554, 035555, 035556, 035557, 035558, 035559
MANUFACTURED BY CHG Hospital Beds Inc, London, Canada
RECALLED BY Stryker Medical Division of Stryker Corporation, Portage, MI
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Each bed has two actuators. The actuators are mounted to the frame by use of a clevis pin design. It was identified that in some situations the actuator may break at the mount end.
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PRODUCT Suction Canister with Lid 490 cc, RX Only
RECALL NUMBER Z-2239-2016
CODE Lot number 2150013, 20150014
MANUFACTURED & RECALLED BY Hologic, Inc, Marlborough, MA
QUANTITY 16,870
DISTRIBUTION Nationwide and internationally
REASON Cracks ATEC Canister Lids.
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PRODUCT Tapered Router, 2.3MM
RECALL NUMBER Z-2238-2016
CODE Product number: 5407-FA2-023; lot number: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
MANUFACTURED & RECALLED BY Stryker Instruments Div of Stryker Corporation, Portage, MI
QUANTITY 3,163
DISTRIBUTION Nationwide
REASON A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages.
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PRODUCT Trach-Vac Endotracheal Tubes
RECALL NUMBER Z-2243-2016
CODE Model number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90; Lot number: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N, O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N, O)
MANUFACTURED & RECALLED BY Parker Medical, Highland Ranch, CO
QUANTITY 5,500 units
DISTRIBUTION KY, MO, FL, TN, TX
REASON Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes (Endotracheal tube, with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
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PRODUCT Modified Linear Standard/Lateral Neck Trails with Spring Sides
RECALL NUMBER Z-2242-2016
CODE Reference number: S-200635, S-200636; lot number: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
MANUFACTURED & RECALLED BY Encore Medical, LP, Austin, TX
QUANTITY 14 (7 sets)
DISTRIBUTION CO, ID, TX
REASON Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
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PRODUCT Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)
RECALL NUMBER Z-2241-2016
CODE Device listing number D017878, lot number 5243MA, 15243MB
MANUFACTURED & RECALLED BY CSL Behring GmbH, Marburg, Germany
QUANTITY 898 units
DISTRIBUTION Nationwide
REASON Reagent lots number 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
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PRODUCT Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit
RECALL NUMBER Z-2244-2016
CODE Catalog number: MRXP 200; serial number: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166
MANUFACTURED & RECALLED BY Bayer Healthcare, Indianola, PA
QUANTITY 42 units
DISTRIBUTION NY
REASON Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.
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PRODUCT TSP Hip Fracture Plating System
RECALL NUMBER Z-2240-2016
CODE Part number / Description:
14-451002 130 DEG 2-HOLE LEFT NECK FX
14-451004 130 DEG 4-HOLE LEFT NECK FX
14-451070 7.5MM TELESCOPE LAG SCR 70MM
14-451075 7.5MM TELESCOPE LAG SCR 75MM
14-451080 7.5MM TELESCOPE LAG SCR 80MM
14-451085 7.5MM TELESCOPE LAG SCR 85MM
14-451090 7.5MM TELESCOPE LAG SCR 90MM
14-451095 7.5MM TELESCOPE LAG SCR 95MM
14-451100 7.5MM TELESCOPE LAG SCR 100MM
14-451102 130 DEG 2-HOLE RIGHT NECK FX
14-451104 130 DEG 4-HOLE RIGHT NECK FX
14-451105 7.5MM TELESCOPE LAG SCR 105MM
14-451110 7.5MM TELESCOPE LAG SCR 110MM
14-451115 7.5MM TELESCOPE LAG SCR 115MM
14-451120 7.5MM TELESCOPE LAG SCR 120MM
14-451125 7.5MM TELESCOPE LAG SCR 125MM
14-451130 7.5MM TELESCOPE LAG SCR 130MM
14-451500 ANGLE GUIDE 130 DEG
14-451502 GUIDE WIRE 3.0MM
14-451503 GUIDE PIN DRIVER 3.0MM
14-451504 TARGETING GUIDE 130 DEG LEFT
14-451505 TARGETING GUIDE 130 DEG RIGHT
14-451509 JIG ATTACHMENT DRIVER 3.5MM
14-451510 NON-LOCK GUIDE SLEEVE 7.5MM
14-451511 LOCKING GUIDE SLEEVE 7.5MM
14-451512 ENTRY TROCAR 7.5 MM
14-451513 DRILL BIT 3.0MM
14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM
14-451526 STEP DRILL CANNULATED 7.5MM
14-451527 STEP DRILL NON-CANN 7.5MM
14-451528 TSP HIP FX TAP 7.5MM
14-451529 HEX DRIVER NECK SLEEVE 5.0MM
14-451530 DRIVER CONNECTOR SHAFT 5.0MM
14-451531 HEX DRIVER NECK SHAFT 3.5MM
14-451532 INSERTER LIMITED COLLAPSE
14-451533 DEPTH GAUGE LIMITED COLLAPSE
14-451535 SCREW GUIDE SLEEVE 4.5MM
14-451536 TROCAR 4.5MM SCREW
14-451537 DRILL GUIDE LOCKING 3.5MM
14-451538 DRILL GUIDE NON-LOCK 3.5MM
14-451539 DRILL BIT 3.5MM
14-451540 SCREW DEPTH GAUGE 4.5MM
14-451541 SCREW DEPTH GAUGE HOOK 4.5MM
14-451542 TSP HIP FX CORTICAL TAP 4.5MM
14-451543 DRIVER 5.0 HEX/3.5 HEXALOBE
14-451544 CONNECTOR SHAFT 4.5MM SCREW
14-451546 T HANDLE W/ HUDSON
14-451550 IMPACTION HANDLE
14-451551 IMPACTION GUIDE PAD
14-451552 IMPACTION PLATE PAD
14-451554 GUIDE WIRE ALIGNMENT ARM
14-451560 GUIDE WIRE PUSHER 2.8MM
14-451561 GUIDE WIRE PLACEMENT TROCAR
14-451562 GUIDE WIRE PLACEMENT SLEEVE
14-451565 SCREW EXTRACTOR 7.5MM SCREW
14-451567 SCREW EXTRACTOR 4.5MM SCREW
14-451568 LAG SCREW REMOVAL TOOL 7.5MM
14-451570 BONE HOOK
14-451571 BALL SPIKE PUSHER
14-451573 REDUCTION TOOL
14-451580 NECK FX INSTRUMENT CASE
14-453005 LIMITED COLLAPSE SLEEVE 5MM
14-453010 LIMITED COLLAPSE SLEEVE 10MM
14-453015 LIMITED COLLAPSE SLEEVE 15MM
14-453020 LIMITED COLLAPSE SLEEVE 20MM
14-454014 4.5MM CORT LOCK SCREW 14MM
14-454016 4.5MM CORT LOCK SCREW 16MM
14-454018 4.5MM CORT LOCK SCREW 18MM
14-454020 4.5MM CORT LOCK SCREW 20MM
14-454022 4.5MM CORT LOCK SCREW 22MM
14-454024 4.5MM CORT LOCK SCREW 24MM
14-454026 4.5MM CORT LOCK SCREW 26MM
14-454028 4.5MM CORT LOCK SCREW 28MM
14-454030 4.5MM CORT LOCK SCREW 30MM
14-454032 4.5MM CORT LOCK SCREW 32MM
14-454034 4.5MM CORT LOCK SCREW 34MM
14-454036 4.5MM CORT LOCK SCREW 36MM
14-454038 4.5MM CORT LOCK SCREW 38MM
14-454040 4.5MM CORT LOCK SCREW 40MM
14-454042 4.5MM CORT LOCK SCREW 42MM
14-454044 4.5MM CORT LOCK SCREW 44MM
14-454046 4.5MM CORT LOCK SCREW 46MM
14-454048 4.5MM CORT LOCK SCREW 48MM
14-454050 4.5MM CORT LOCK SCREW 50MM
14-454052 4.5MM CORT LOCK SCREW 52MM
14-454054 4.5MM CORT LOCK SCREW 54MM
14-454056 4.5MM CORT LOCK SCREW 56MM
14-454058 4.5MM CORT LOCK SCREW 58MM
14-454060 4.5MM CORT LOCK SCREW 60MM
14-454065 4.5MM CORT LOCK SCREW 65MM
14-454070 4.5MM CORT LOCK SCREW 70MM
14-454075 4.5MM CORT LOCK SCREW 75MM
14-454080 4.5MM CORT LOCK SCREW 80MM
14-454085 4.5MM CORT LOCK SCREW 85MM
14-454090 4.5MM CORT LOCK SCREW 90MM
14-454095 4.5MM CORT LOCK SCREW 95MM
14-455014 4.5MM CORT NON-LOCK SCREW 44MM
14-455016 4.5MM CORT NON-LOCK SCREW 16MM
14-455018 4.5MM CORT NON-LOCK SCREW 18MM
14-455020 4.5MM CORT NON-LOCK SCREW 20MM
14-455022 4.5MM CORT NON-LOCK SCREW 22MM
14-455024 4.5MM CORT NON-LOCK SCREW 24MM
14-455026 4.5MM CORT NON-LOC
All lots
MANUFACTURED & RECALLED BY Biomet, Inc, Warsaw, IN
QUANTITY 5458 units
DISTRIBUTION Nationwide
REASON The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Replace Select Tapered TiU NP 3.5x11.5mm
RECALL NUMBER Z-2237-2016
CODE Article number 36105, lot number 13030677
MANUFACTURED & RECALLED BY Nobel Biocare USA LLC, Yorba Linda, CA
QUANTITY 53 units total (33 units in US)
DISTRIBUTION OR, OH, NY
REASON Incorrect top label on an implant package.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only
RECALL NUMBER D-1441-2016
CODE NDC 0054-0390-41, lot number 560185A
MANUFACTURED BY Boehringer Ingelheim Roxane, Inc, Columbus, OH
RECALLED BY West-Ward Columbus Inc, Columbus, OH
QUANTITY 1,182 bottles
DISTRIBUTION Nationwide
REASON Failed Impurities/Degradation Specification; 9 month stability.
ACTION Quarantine and contact your supplier for instructions.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Duloxetine Delayed-release Capsules 60 mg Gold 1000
RECALL NUMBER D-1255-2016
CODE NDC 60429-166-10, lot number GS012352
MANUFACTURED & RECALLED BY Golden State Medical Supply, Inc, Camarillo, CA
QUANTITY 2077 bottles total
DISTRIBUTION Nationwide
REASON This is an update to a notice posted on 6/30/16 to include an additional lot number. Due to an incorrect expiration date identified on the container label.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Diazepam Injection, USP 10mg/2mL (5mg/mL)
RECALL NUMBER D-1359-2016
CODE NDC 0409-1273-32, lot number 57660LL
MANUFACTURED & RECALLED BY Hospira Inc, Lake Forest, IL
QUANTITY 373,850 tubes total
DISTRIBUTION Nationwide
REASON This is an update to a notice posted on 6/28/16 to include an additional lot number. Due to a potential for the presence of crystallized Diazepam adhered to the plunger or wall of the Carpuject. May result in localized inflammation, phlebitis, low level allergic response, thromboembolic events or immune response may occur.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT NV Quattro Air & Quattro Air Mask
RECALL NUMBER To be determined
CODE 62702, lot number 1142623
MANUFACTURED & RECALLED BY ResMed, San Diego, CA
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON ResMed identified that a small number of masks labeled and sold as 62702 Quattro Air FFM MED – AMER, lot 1142623, actually contain an NV Quattro Air FFM Large mask.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Dextroamphetamine sulfate, 10 mg, 90 capsules
RECALL NUMBER To be determined
CODE NDC 45963-304-09, lot number 3803J141
MANUFACTURED & RECALLED BY Actavis Pharma, Inc, Parsippany, NJ
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Due to the drug release results at the 18-month stability time-point being marginally outside the minimum specification of 80% at the 8-hour dissolution testing time-point.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Ruby®’s Diocto Liquid, 50 mg/5 mL
RECALL NUMBER To be determined
CODE NDC 0536-0590-85, All lots
MANUFACTURED & RECALLED BY PharmaTech, LLC, Davie, Florida
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON Due to risk of product contamination with Burkholderia cepacia.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Trokendi XR 50 mg Capsules
RECALL NUMBER To be determined
CODE NDC 17772-102-15, lot number 426636
MANUFACTURED & RECALLED BY Supernus Pharmaceuticals, Inc, Winchester, KY
QUANTITY Not available at publication
DISTRIBUTION Nationwide
REASON One bulk lot, during testing of a retain sample, yielded assay results higher than the upper specification limit.
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