FDA Device recall Z-1299-2020
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or… by Covidien, citing there is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1299-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-18 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Reason
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Identifiers
| code_info | Lot - D7H0866X Expiration Date - 2022-08-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.