FDA-Device2020-02-26Class II

Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

Covidien LLC
Hazard

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Sold states
US Nationwide distribution.
Affected count
139,938 units total
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2020

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