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Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11… recallZ-1275-2020 · Covidien LLC · initiated Dec 18, 2019

Class II Terminated All recalls posted in February 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

FDA root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-1275-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 18, 2019
Posted by the FDA
Feb 19, 2020
Recalling firm
Covidien LLC
Quantity
139,938 units total
Product code
GAM
FDA submissions
K000037
Distribution
US Nationwide distribution.

Product description

Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Code information (models, lots, serial numbers)

Lot - A9J0018Y Expiration Date - 2024-08-31

Other devices under the same FDA submission

99 devices cleared under K000037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84769).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page