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Terminated

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 Recall Z-2538-2016 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeHCF
Date Initiated2016-03-24
Date Terminated2020-09-25
Product Quantity45

Reason for Recall

Incorrect expiration date was printed on the product label.

Firm Action

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 [email protected]. 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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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