Z-0019-2021 Class II Terminated
FDA device recall Z-0019-2021 was initiated by Riverpoint Medical, LLC on Aug 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 Sep 8, 2022). Affected quantity: 1886.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2020
- Initiation Date
- Aug 3, 2020
- Termination Date
- Sep 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1886
Product Description
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - 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: 20052017FX
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0019-2021
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026