Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Recall
- Recall Number
- Z-1279-2020
- Event Number
- 84769
- Firm
- Covidien LLC
- FEI Number
- 1219930
- Product Code
- GAM
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- December 18, 2019
- Posted
- February 19, 2020
- Terminated
- August 16, 2022
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908
Description
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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.
US Nationwide distribution.
139,938 units total