Telefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk
Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm during a surgical procedure, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems. These devices are used in laparoscopic procedures for approximating tissues and for percutaneous suturing to close incision sites. The recall is due to a defect where the device's wings may become partially detached from the EFx Shield during use.
The affected products are identified by Product Code EFX002 and Lot numbers 3264480000, 3269990000, and 3270100000. The devices were distributed domestically across the United States and internationally to Belgium and Canada.
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 Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Surgical Suture
- Affected units
- 2,265
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 (4)
- Product Code: EFX002
- Lot numbers: 3264480000
- 3269990000
- 3270100000.
Distribution
Distributed nationwide across the United States.
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