Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Polysorb Braided Absorbable Suture

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Polysorb Braided Absorbable Suture see related information
Date Initiated by Firm December 18, 2019
Date Posted February 19, 2020
Recall Status1 Terminated 3 on August 16, 2022
Recall Number Z-1281-2020
Recall Event ID 84769
510(K)Number K000037  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - 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 - A9H1186Y Expiration Date - 2024-07-31;   2) Lot A9J0015Y Expiration Date - 2024-08-31
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
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
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.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
-
-