—#148177

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

FDA product code: HCF — Instrument, Ligature Passing And Knot Tying
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

Incorrect expiration date was printed on the product label.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA

Timeline

Recall initiated: 2016-03-24
Terminated: 2020-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.