FDA-Device2021-02-10Class II
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Riverpoint Medical, LLC
Hazard
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.
Sold states
US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.
Affected count
3060 units
Manufactured in
825 NE 25th Ave, Portland, OR, United States
Products
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2021Don't want to check this manually?
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