Device product
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021
Product summary
- Event
- Event 86254
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5479
- Official record key
device-enforcement:Z-0014-2021
Official wording
Reason: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Code information: Lot Number: 20051405FX
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.