BEUDAMED
    FDA Recall Open, Classified

    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

    Recall: Z-1735-2024 · Initiated March 27, 2024

    Recall

    Recall Number
    Z-1735-2024
    Event Number
    94309
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    GBX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2024
    Posted
    May 1, 2024
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

    Reason

    Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

    Action

    Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 03/27/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the following: Locate, segregate, and cease use of the affected product, disseminate the notice to those who handle the product. Distributors were directed to notify their customers. CONTACT the appropriate Customer Service group to arrange return of product and with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

    Quantity

    202 cases of 12