Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
FDA Recall #Z-1300-2020 — Class II — December 18, 2019
Product Description
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Reason for Recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Recalling Firm
Covidien LLC — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
139,938 units total
Distribution
US Nationwide distribution.
Code Information
Lot - D7H0404X Expiration Date - 2022-08-31
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated