BEUDAMED
    FDA Recall Terminated

    Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    Recall: Z-1288-2020 · Initiated December 18, 2019

    Recall

    Recall Number
    Z-1288-2020
    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 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    Reason

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

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    139,938 units total