BEUDAMED
    FDA Recall Terminated

    Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.

    Recall: Z-0200-06 · Initiated September 12, 2005

    Recall

    Recall Number
    Z-0200-06
    Event Number
    33506
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2005
    Posted
    November 26, 2005
    Terminated
    March 22, 2006
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.

    Reason

    There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

    Action

    Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.

    Distribution

    Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.

    Quantity

    2520