BEUDAMED
    FDA Recall Terminated

    Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)

    Recall: Z-0942-2015 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-0942-2015
    Event Number
    70081
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    OFA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 23, 2014
    Posted
    January 8, 2015
    Terminated
    June 8, 2015
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)

    Reason

    According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

    Action

    Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

    Distribution

    Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

    Quantity

    42 kits