BEUDAMED
    FDA Recall Open, Classified

    3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

    Recall: Z-1170-2024 · Initiated January 12, 2024

    Recall

    Recall Number
    Z-1170-2024
    Event Number
    93825
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    LWK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 12, 2024
    Posted
    February 21, 2024
    Address
    2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001

    Description

    3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

    Reason

    3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)."

    Action

    3M issued a Medical Device Safety Notification - First Notice to its consignees on 01/12/2024 via USPS certified mail and email. The notice explained the issue and its decision to notify its consignees of an added caution statement regarding the use of the product: Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F). Users were asked to take the following actions: "" Ensure this safety notification is passed to all those who need to be aware within your organization or to any department where the affected product has been transferred. " Continue to use the product as intended, following the additional caution statement above. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the additional caution statement. " Email the completed form to [email protected]." For additional questions or need to report an adverse event, contact the 3M Health Care Customer Helpline at 1-800-228-3957, option 7.

    Distribution

    Worldwide distribution.

    Quantity

    764,580 blades