BEUDAMED
    FDA Recall Terminated

    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.

    Recall: Z-2242-2010 · Initiated July 20, 2010

    Recall

    Recall Number
    Z-2242-2010
    Event Number
    56285
    Firm
    Civco Medical Instruments Inc
    FEI Number
    1937223
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 20, 2010
    Posted
    August 20, 2010
    Terminated
    April 13, 2012
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.

    Reason

    Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.

    Action

    CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.

    Distribution

    Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.

    Quantity

    22 boxes