BEUDAMED
    FDA Recall Terminated

    BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.

    Recall: Z-0467-06 · Initiated November 17, 2005

    Recall

    Recall Number
    Z-0467-06
    Event Number
    34199
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    GCD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2005
    Posted
    February 4, 2006
    Terminated
    March 3, 2008
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.

    Reason

    The catheter connector could not be sufficiently tightened to secure the catheter tubing.

    Action

    Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.

    Distribution

    The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.

    Quantity

    1410 units