FDA Device recall Z-0949-2021
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 by Riverpoint Medical, citing due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-09 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Riverpoint Medical |
| Distribution | NJ |
Product
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Reason
Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.
Identifiers
| code_info | Lot # 19062715X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0949-2021%22
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