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The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Covidien Surgiwand II Suction and Irrigation Devices with FDA registration numbers, MDR-01054, MDR-01055 and MDR-01145, manufactured by Covidien-USA, imported and distributed by Medtronic Philippines, Inc.:

Item Code Description Affected Lot Numbers
178083 Surgiwand™ II Auto Suture™ Suction and Irrigation Device 5 mm P9D0020Y P9F1565Y P0B1393Y P0F0332Y P0G0436Y
P9D1478Y P9F1566Y P0B1394Y P0F0333Y P0G0483Y
P9E1057Y P9G0718Y P0C0405Y P0F0334Y P0G0484Y
P9E1058Y P9G0719Y P0C0406Y P0F0335Y P0G0542Y
P9E1059Y P9K1412Y P0C0413Y P0F0336Y P0G0543Y
P9E1064Y P9K1444Y P0C1101Y P0F0337Y P0G0544Y
P9E1065Y P9D0022Y P0C1102Y P0F0646Y P0G0545Y
P9E1066Y P9D0021Y P0C1554Y P0F0647Y P0G0717Y
P9E1121Y P9K1493Y P0C1555Y P0F0648Y P0G0718Y
P9E1122Y P9K1494Y P0C1556Y P0F0649Y P0H0176Y
P9E1123Y P9K1495Y P0E1077Y P0F0718Y P0H0177Y
P9E1124Y P9K1496Y P0E1078Y P0F0944Y P0H0213Y
P9E1197Y P9K1497Y P0E1079Y P0F0945Y P0H0430Y
P9E1380Y P9K1616Y P0E1086Y P0F0946Y P0J0017Y
P9E1381Y P9K1615Y P0E1087Y P0F0947Y P0J0627Y
P9E1382Y P0A1508Y P0E1088Y P0F0948Y P0K0130Y
P9E1383Y P0A1509Y P0E1177Y P0G0034Y P0K0158Y
P9F1162Y P0B1130Y P0E1178Y P0G0035Y P0K0373Y
P9F1163Y P0B1131Y P0E1179Y P0G0036Y P0L0480
P9F1280Y P0A1510Y P0F0120Y P0G0037Y P0L1176
P9F1281Y P0B1262Y P0F0121Y P0G0038Y P0L1177
P9F1563Y P0B1291Y P0F0122Y P0G0059Y P0L1261
P9F1564Y P0B1292Y P0F0123Y P0G0060Y P0L1399
178093 Surgiwand™ II Auto Suture™ Suction and Irrigation Device with   L-Hook Tip 5 mm P9C1632Y P9E0016Y P9K1503Y P0E1281Y P0F0872Y
P9C1634Y P9E0017Y P9K1618Y P0E1313Y P0G0649Y
P9C1635Y P9E1007Y P0B1134Y P0E1314Y P0G0650Y
P9C1636Y P9E1279Y P0B1135Y P0E1393Y P0H0179Y
P9D1175Y P9E1325Y P0B1268Y P0F0126Y P0H0180Y
P9D1177Y P9E1326Y P0B1399Y P0F0127Y P0J0578Y
P9D1176Y P9E1328Y P0C0411Y P0F0440Y P0J0579Y
P9D1178Y P9F1164Y P0C1105Y P0F0441Y P0J0629Y
P9D1346Y P9F1568Y P0C1557Y P0F0443Y P0K0336Y
P9D1347Y P9K1445Y P0C1558Y P0F0651Y P0L1175
P9D1480Y P9K1446Y P0E1180Y P0F0652Y P0L1262
P9D1481Y P9K1501Y P0E1181Y P0F0846Y P0L1304
P9B1359Y P9K1502Y  
178094 Surgiwand™ II Auto Suture™ Suction and Irrigation Device with Spatula Tip 5 mm P9D1179Y P0B1136Y P0E1173Y P0E1384Y P0K0334Y
P9D1180Y P0B1400Y P0E1383Y P0G0739Y  
  Covidien Best Practices Kits containing Surgiwand™ II Auto Suture™ Suction and Irrigation  
  Affected Kit Parent Code Description  
  00C9010 00C9010 LAP CHOLE BP KIT  

Medtronic International, Ltd. initiated the voluntary recall of the above-mentioned specific lots/batches of Covidien Surgiwand II Suction and Irrigation Devices after customers reported foreign particles in the device tubing. On their investigation, they identified an assembly process that could potentially damage the “Y-connector,” allowing for small pieces of the connector to move through the device tubing.

Use of this device with this issue may result in infection, allergic reaction. Manufacturing process improvement have been implemented to remediate this issue. There have been no reports of serious injury to this issue.

                 

In light of the foregoing, all concerned healthcare professional, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Covidien Surgiwand II Suction and Irrigation Devices.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

 

Dissemination of this advisory to all concerned is hereby requested.

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