Z-0083-2018 Class II Terminated

Recalled by Teleflex Medical — Research Triangle Park, NC

Recall Details

Product Type
Devices
Report Date
November 15, 2017
Initiation Date
October 5, 2017
Termination Date
January 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,710 units

Product Description

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

Reason for Recall

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

Distribution Pattern

Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea

Code Information

Lot numbers: 73A1700701, 73H1600582, 73B1700183, 73H1600583, 73B1700567, 73H1600663, 73C1600069, 73H1600664, 73C1600070, 73H1600665, 73C1600071, 73H1600666, 73C1700288, 73H1600667, 73C1700289, 73H1600668, 73C1700290, 73J1600135, 73C1700292, 73J1600136, 73C1700300, 73J1600137, 73F1600036, 73J1600138, 73F1600037, 73J1600139, 73F1600038, 73J1600414, 73F1600039, 73J1600415, 73F1600040, 73J1600416, 73F1600689, 73K1600118, 73F1600690, 73K1600457, 73F1600691, 73K1600458, 73F1600692, 73K1600497, 73F1600693, 73K1600514, 73F1600694, 73K1600614, 73G1600151, 73L1600528, 73G1600431, 73L1600529, 73G1600432, 73L1600530, 73G1600716, 73L1600531, 73G1600717, 73L1600532, 73H1500014, 73L1600563, 73H1500015, 73M1600200, 73H1500016, 73M1600201, 73H1600173, 73M1600202, 73H1600174, 73M1600279