Date Initiated by Firm | December 18, 2019 |
Date Posted | February 19, 2020 |
Recall Status1 |
Terminated 3 on August 16, 2022 |
Recall Number | Z-1283-2020 |
Recall Event ID |
84769 |
510(K)Number | K000037 |
Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
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Product | Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. |
Code Information |
1) Lot - A9H1189Y Expiration Date - 2024-07-31; 2) Lot - A9J0345Y Expiration Date - 2024-08-31 |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
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For Additional Information Contact | 800-962-9888 Ext. 2 |
Manufacturer Reason for Recall | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. |
FDA Determined Cause 2 | Equipment maintenance |
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. |
Quantity in Commerce | 139,938 units total |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GAM
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