BEUDAMED
    FDA Recall Terminated

    IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641

    Recall: Z-1122-04 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-1122-04
    Event Number
    29496
    Firm
    Medex Inc
    FEI Number
    1526863
    Product Code
    BZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    July 22, 2004
    Terminated
    February 7, 2005
    Address
    6250 Shier Rings Rd, Dublin, OH, 43016-1270

    Description

    IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641

    Reason

    The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

    Action

    Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.

    Distribution

    California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.

    Quantity

    400 units