Z-1281-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- December 18, 2019
- Termination Date
- August 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,938 units total
Product Description
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - 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.
Distribution Pattern
US Nationwide distribution.
Code Information
1) Lot - A9H1186Y Expiration Date - 2024-07-31; 2) Lot A9J0015Y Expiration Date - 2024-08-31