Device product
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
Z-2538-2016
Product summary
- Firm
- Teleflex Medical
- Event
- Event 74683
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45
- Official record key
device-enforcement:Z-2538-2016
Official wording
Reason: Incorrect expiration date was printed on the product label.
Code information: Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347
Distribution pattern: Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
Derived failure modes
-
Unknown
Incorrect expiration date was printed on the product label.