Z-0016-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 3, 2020
- Termination Date
- September 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3110
Product Description
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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.
Reason for Recall
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: 20051814FX