BEUDAMED
    FDA Recall Terminated

    Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015

    Recall: Z-0800-05 · Initiated March 28, 2005

    Recall

    Recall Number
    Z-0800-05
    Event Number
    31491
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2005
    Posted
    May 6, 2005
    Terminated
    March 4, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015

    Reason

    The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.

    Action

    Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy the needle in the tray and replace it with the replacement needles when the tray is opened prior to the procedure.

    Distribution

    Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela

    Quantity

    127,340 trays