Z-0083-2018 Class II Terminated
FDA device recall Z-0083-2018 was initiated by Teleflex Medical on October 5, 2017 and is designated Class II. Reason for recall: The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. The recall status is terminated (terminated January 20, 2023). Affected quantity: 13,710 units.
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