Recall Z-2538-2016
Teleflex Medical · initiated March 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
Incorrect expiration date was printed on the product label.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Details
- Recall number
- Z-2538-2016
- Initiated
- March 24, 2016
- Terminated
- September 25, 2020
- Product code
- HCF – Instrument, Ligature Passing And Knot Tying
- Quantity
- 45
- Distribution
- Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC