Recall Z-0759-2017
Teleflex Medical · initiated November 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Codes / lots: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.
Reason for recall
The devices wings may become partially detached from the EFx Shield during use.
FDA-determined cause: Other
Action taken
Consignees were notified via letter on 11/16/2016.
Details
- Recall number
- Z-0759-2017
- Initiated
- November 16, 2016
- Terminated
- December 13, 2017
- Product code
- HCF – Instrument, Ligature Passing And Knot Tying
- Quantity
- 2265 units
- Distribution
- Domestic; US Nationwide; International: Belgium, Canada.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC