Z-1275-2020 Class II Terminated
FDA device recall Z-1275-2020 was initiated by Covidien LLC on Dec 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 Aug 16, 2022). Affected quantity: 139,938 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 26, 2020
- Initiation Date
- Dec 18, 2019
- Termination Date
- Aug 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139,938 units total
Product Description
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - 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 - A9J0018Y Expiration Date - 2024-08-31
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1275-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026