FDA-Device2020-02-26Class II

Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

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
Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1287-2020

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