BEUDAMED
    FDA Recall Terminated

    Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.

    Recall: Z-0885-2007 · Initiated May 22, 2007

    Recall

    Recall Number
    Z-0885-2007
    Event Number
    37996
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2007
    Posted
    July 10, 2007
    Terminated
    July 7, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.

    Reason

    The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

    Action

    Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.

    Distribution

    Nationwide.

    Quantity

    39