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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Hazard
- 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
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