BEUDAMED
    FDA Recall Terminated

    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach

    Recall: Z-0964-2017 · Initiated December 6, 2016

    Recall

    Recall Number
    Z-0964-2017
    Event Number
    75941
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 6, 2016
    Posted
    January 7, 2017
    Terminated
    June 8, 2017
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach

    Reason

    A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

    Action

    Customer notification letters were sent 12/06/16. Customers were asked to use the criteria of Item Number and Expiration Date to determine if any affected product remains in inventory. Use of the products from the affected item number and expiration date should be discontinued. Customers are instructed to follow the web link below to complete the Recall Effectiveness Check Form and indicate if any devices with the affected item number and expiration date listed above remain in inventory. ONLINE form must be completed even if no affected product is found. Use Stryker Sustainability Solutions Ship To Account Number as complete the form. If do not know your Ship To Account Number, contact local sales representative or call Stryker Sustainability Solutions Customer Care at 1-888-763-8803 to obtain this number. If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to facility for all affected devices in scope of this recall that are returned. Address any questions regarding the recall to Novasyte by calling (760) 279-3126 or emailing [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1-888-763-8803 http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

    Distribution

    U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA.