National Recall Alert Center - Immediate Warning Alert Notification
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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 1 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
2 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 3 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.
------4 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 5 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 6 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, 7 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, 8 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 9 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 10 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
11 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 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451105 7.5MM TELESCOPE LAG SCR 105MM 12 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-453005 LIMITED COLLAPSE SLEEVE 5MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-453010 LIMITED COLLAPSE SLEEVE 10MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-453015 LIMITED COLLAPSE SLEEVE 15MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-453020 LIMITED COLLAPSE SLEEVE 20MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-454014 4.5MM CORT LOCK SCREW 14MM 14-451500 ANGLE GUIDE 130 DEG 14-454016 4.5MM CORT LOCK SCREW 16MM 14-451502 GUIDE WIRE 3.0MM 14-454018 4.5MM CORT LOCK SCREW 18MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-454020 4.5MM CORT LOCK SCREW 20MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-454022 4.5MM CORT LOCK SCREW 22MM 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-454024 4.5MM CORT LOCK SCREW 24MM 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-454026 4.5MM CORT LOCK SCREW 26MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5MM 14-454028 4.5MM CORT LOCK SCREW 28MM 14-451511 LOCKING GUIDE SLEEVE 7.5MM 14-454030 4.5MM CORT LOCK SCREW 30MM 14-451512 ENTRY TROCAR 7.5 MM 14-454032 4.5MM CORT LOCK SCREW 32MM 14-451513 DRILL BIT 3.0MM 14-454034 4.5MM CORT LOCK SCREW 34MM 14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM 14-454036 4.5MM CORT LOCK SCREW 36MM 14-451526 STEP DRILL CANNULATED 7.5MM 14-454038 4.5MM CORT LOCK SCREW 38MM 14-451527 STEP DRILL NON-CANN 7.5MM 14-454040 4.5MM CORT LOCK SCREW 40MM 14-451528 TSP HIP FX TAP 7.5MM 14-454042 4.5MM CORT LOCK SCREW 42MM 14-451529 HEX DRIVER NECK SLEEVE 5.0MM 14-454044 4.5MM CORT LOCK SCREW 44MM 14-451530 DRIVER CONNECTOR SHAFT 5.0MM 14-454046 4.5MM CORT LOCK SCREW 46MM 14-451531 HEX DRIVER NECK SHAFT 3.5MM 14-454048 4.5MM CORT LOCK SCREW 48MM 14-451532 INSERTER LIMITED COLLAPSE 14-454050 4.5MM CORT LOCK SCREW 50MM 14-451533 DEPTH GAUGE LIMITED COLLAPSE 14-454052 4.5MM CORT LOCK SCREW 52MM 14-451535 SCREW GUIDE SLEEVE 4.5MM 14-454054 4.5MM CORT LOCK SCREW 54MM 14-451536 TROCAR 4.5MM SCREW 14-454056 4.5MM CORT LOCK SCREW 56MM 14-451537 DRILL GUIDE LOCKING 3.5MM 14-454058 4.5MM CORT LOCK SCREW 58MM 14-451538 DRILL GUIDE NON-LOCK 3.5MM 14-454060 4.5MM CORT LOCK SCREW 60MM 14-451539 DRILL BIT 3.5MM 14-454065 4.5MM CORT LOCK SCREW 65MM 14-451540 SCREW DEPTH GAUGE 4.5MM 14-454070 4.5MM CORT LOCK SCREW 70MM 14-451541 SCREW DEPTH GAUGE HOOK 4.5MM 14-454075 4.5MM CORT LOCK SCREW 75MM 14-451542 TSP HIP FX CORTICAL TAP 4.5MM 14-454080 4.5MM CORT LOCK SCREW 80MM 14-451543 DRIVER 5.0 HEX/3.5 HEXALOBE 14-454085 4.5MM CORT LOCK SCREW 85MM 14-451544 CONNECTOR SHAFT 4.5MM SCREW 14-454090 4.5MM CORT LOCK SCREW 90MM 14-451546 T HANDLE W/ HUDSON 14-454095 4.5MM CORT LOCK SCREW 95MM 14-451550 IMPACTION HANDLE 14-455014 4.5MM CORT NON-LOCK SCREW 14-451551 IMPACTION GUIDE PAD 44MM 14-451552 IMPACTION PLATE PAD 14-455016 4.5MM CORT NON-LOCK SCREW 14-451554 GUIDE WIRE ALIGNMENT ARM 16MM 14-451560 GUIDE WIRE PUSHER 2.8MM 14-455018 4.5MM CORT NON-LOCK SCREW 14-451561 GUIDE WIRE PLACEMENT TROCAR 18MM 14-451562 GUIDE WIRE PLACEMENT SLEEVE 14-455020 4.5MM CORT NON-LOCK SCREW 14-451565 SCREW EXTRACTOR 7.5MM SCREW 20MM 14-451567 SCREW EXTRACTOR 4.5MM SCREW 14-455022 4.5MM CORT NON-LOCK SCREW 14-451568 LAG SCREW REMOVAL TOOL 7.5MM 22MM 14-451570 BONE HOOK 14-455024 4.5MM CORT NON-LOCK SCREW 14-451571 BALL SPIKE PUSHER 24MM 14-451573 REDUCTION TOOL 14-455026 4.5MM CORT NON-LOC 14-451580 NECK FX INSTRUMENT CASE 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 13 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.
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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.
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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.
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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.
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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.
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PRODUCT NV Quattro Air & Quattro Air Mask RECALL NUMBER To be determined CODE 62702, lot number 1142623 MANUFACTURED & RECALLED BY ResMed, San Diego, CA 14 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.
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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.
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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.
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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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