Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicat...
FDA Recall #Z-1296-2020 — Class II — December 18, 2019
Product Description
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
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 - D7H0946X Expiration Date - 2022-08-31
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated