Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue
FDA device recall Z-1280-2020 · posted 2020-02-19 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Action taken
- On December 18, 2109, Medtronic issued Urgent Medical Device Recall and Return Form notices to customers via courier service. Customers were advised to take the following required actions: 1. Please immediately quarantine and discontinue use of the affected item code and lot listed within the notice. 2. Please return affected product as indicated within the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed any of the Polysorb braided or Biosyn monofilament absorbable sutures listed on the recall notice, please promptly forward the information from the letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 139,938 units total
- Distribution
- US Nationwide distribution.
- Date initiated
- 2019-12-18
- Date posted
- 2020-02-19
- Date terminated
- 2022-08-16
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOFILAMENT BIOSYN SUTURE (K000037) | United States Surgical, A Division of Tyco Healthc | 2000-03-30 |