# FDA recall Z-0949-2021

> **Riverpoint Medical, LLC** · Class II · device recall initiated 2020-12-09.

## 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 for recall

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.

## Distribution

US: NJ  OUS: Germany, Croatia, Italy, India, Poland and Spain.

## Key facts

- **Recall number:** Z-0949-2021
- **Recalling firm:** Riverpoint Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-09
- **Report date:** 2021-02-10
- **Termination date:** 2023-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portland, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2021

## Citation

> AI Analytics. FDA recall Z-0949-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0949-2021. Source: US FDA. Licensed CC0.

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