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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.

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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

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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