Device product
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Z-1282-2020
Product summary
- Firm
- Covidien LLC
- Event
- Event 84769
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139,938 units total
- Official record key
device-enforcement:Z-1282-2020
Official wording
Reason: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code information: 1) Lot - A9H0927Y Expiration Date - 2024-07-31; 2) Lot - A9H1187Y Expiration Date - 2024-07-31; 3) Lot - A9J0383Y Expiration Date - 2024-08-31; 4) Lot - A9J0428Y Expiration Date - 2024-08-31
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.