Z-0029-2021 Class II Terminated
FDA device recall Z-0029-2021 was initiated by Riverpoint Medical, LLC on August 3, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 8, 2022). Affected quantity: 2499.
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
- 2499
Product Description
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - 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: 20060116FX