The Recall Desk
LowFDA (Devices)·Z-2538-2016·Announced 2016-08-24

Telefax Medical Recalls Weck EFx Fascial Closure System for Labeling Error

Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation and labeling issue (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System, a sterile, prescription-only medical device intended to repair port side defects following laparoscopic surgery. The recall is due to an incorrect expiration date printed on the product label.

The affected products are distributed nationwide to California, Colorado, Iowa, Kansas, Maryland, Michigan, New York, North Carolina, and Pennsylvania. The recall covers specific lot numbers for Product Codes EFXCT1 and EFXSP1.

Healthcare providers and consumers should stop using the affected devices and contact Teleflex Medical for further instructions or a replacement.

The recalled product

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
Manufacturer
Teleflex Medical
Affected units
45

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

Distributed nationwide across the United States.

The notice also names 9 states specifically: