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Recall Observatory FDA recall evidence

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

March 24, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    Incorrect expiration date was printed on the product label.