BEUDAMED
    FDA Recall Open, Classified

    3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape

    Recall: Z-0252-2023 · Initiated October 6, 2022

    Recall

    Recall Number
    Z-0252-2023
    Event Number
    90989
    Firm
    3M Healthcare Business
    FEI Number
    2126770
    Product Code
    PUI
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    October 6, 2022
    Posted
    November 18, 2022
    Address
    2510 Conway Ave E, Saint Paul, MN, 55144-4147

    Description

    3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape

    Reason

    During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

    Action

    The firm began disseminating an URGENT Product Recall notice their consignees by email or letter beginning 10/06/2022. The notice explained the issue and requested the following: Distributors: "Actions Requested: 1. Immediately discontinue distribution of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. 3. Complete the Distributor Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to [email protected]. 4. Notify any of your customers who have purchased this product using the Customer Letter and Customer Acknowledgement Form provided. 5. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email to [email protected]." Direct accounts: "Actions Requested: 1. Immediately cease use of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. NOTE: if you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 3. Complete the Customer Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to [email protected]. 4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t

    Distribution

    Worldwide distribution.

    Quantity

    84,000 units