Z-1294-2020 Class II Terminated
FDA device recall Z-1294-2020 was initiated by Covidien LLC on December 18, 2019 and is designated Class II. Reason for recall: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. The recall status is terminated (terminated August 16, 2022). Affected quantity: 139,938 units total.
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 UD 3/0 30 P-14, Item Code SL5679 - 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
Lot -A9H0847FY Expiration Date - 2024-07-31