BEUDAMED
    FDA Recall Open, Classified

    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

    Recall: Z-0844-2024 · Initiated December 21, 2023

    Recall

    Recall Number
    Z-0844-2024
    Event Number
    93768
    FEI Number
    1282497
    Product Code
    GAR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 21, 2023
    Posted
    January 29, 2024
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

    Reason

    Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

    Action

    On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact [email protected] for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor. Pass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed. If you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1 ***Updated 4/1/2024*** Firm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.

    Distribution

    Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.

    Quantity

    46,812 US; 68,976 OUS