Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Recall Z-1287-2020 · Posted 2020-02-19
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2019-12-18
Date Terminated2022-08-16
Product Quantity139,938 units total
Reason for Recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Firm Action
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
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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