BEUDAMED
    FDA Recall Terminated

    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

    Recall: Z-1023-2016 · Initiated February 4, 2016

    Recall

    Recall Number
    Z-1023-2016
    Event Number
    73261
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 4, 2016
    Posted
    February 26, 2016
    Terminated
    November 7, 2016
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

    Reason

    Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

    Action

    Medtronic sent an Urgent Medical Device Safety Alert dated February 2016 to all consignees on February 4, 2016. The letter described the problem and the product involved in the recall. Advised consignees to review the Terumo CVS Urgent Safety Alert and follow the instructions in the Recommended Action Section of the Urgent Safety Alert letter. Requested consignees to completed the Customer Confirmation Certificate and Email completed form(s) to [email protected]. If email is not available, fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic representative or Lifeline Technical Support at 877-526-7890. For questions regarding this recall call 763-391-9000.

    Distribution

    Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.

    Quantity

    9890 (7773 US, 2117 OUS)