BEUDAMED
    FDA Recall Open, Classified

    3M Attest Steam Chemical Integrators, REF 1243A

    Recall: Z-1609-2023 · Initiated April 6, 2023

    Recall

    Recall Number
    Z-1609-2023
    Event Number
    92041
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    JOJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 6, 2023
    Posted
    May 18, 2023
    Address
    2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001

    Description

    3M Attest Steam Chemical Integrators, REF 1243A

    Reason

    3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

    Action

    3M issued an URGENT: Voluntary Product Recall to its consignees beginning 04/06/2023 via email or USPS certified mail. The notice explained the issue, hazard, and requested that the use of the affected product cease, identify any in stock product and dispose of it. The firm will replace the product. To request product replacement for affected lots disposed, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to [email protected]. Please note, replacement product can only be provided following 3M receipt of the completed form. If you have questions, please the 3M Health Care Customer Helpline at 1-800-228-3957, option #7.

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.

    Quantity

    16,229,000 units