Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Reported: February 10, 2021 Initiated: December 9, 2020 #Z-0949-2021
Product Description
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.
Details
- Recalling Firm
- Riverpoint Medical, LLC
- Units Affected
- 3060 units
- Distribution
- US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
- Location
- Portland, OR
Frequently Asked Questions
What product was recalled? ▼
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307. Recalled by Riverpoint Medical, LLC. Units affected: 3060 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0949-2021.
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