BEUDAMED
    FDA Recall Terminated

    CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.

    Recall: Z-1607-2011 · Initiated January 21, 2011

    Recall

    Recall Number
    Z-1607-2011
    Event Number
    57759
    Firm
    Civco Medical Instruments Inc
    FEI Number
    1937223
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 21, 2011
    Posted
    March 8, 2011
    Terminated
    July 9, 2013
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.

    Reason

    Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.

    Action

    The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.

    Distribution

    Nationwide Distribution -- WA, CA, and MO.

    Quantity

    31/24-cover boxes