BEUDAMED
    FDA Recall Open, Classified

    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    Recall: Z-0038-2025 · Initiated August 14, 2024

    Recall

    Recall Number
    Z-0038-2025
    Event Number
    95273
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    FRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 14, 2024
    Posted
    October 9, 2024
    Address
    2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001

    Description

    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    Reason

    Contamination with foreign substance matter

    Action

    3M notified its sole consignee (a distributor) on 08/14/2024 via email. The notice explained the issue and requested the following: Identify and discontinue distribution of affected product, notify those to whom you distributed the product, and return the product to the seller. The firm provided a letter for the distributor to send to its customers.

    Distribution

    International distribution to the country of South Korea.

    Quantity

    10,000 units