BEUDAMED
    FDA Recall Terminated

    Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico

    Recall: Z-1087-05 · Initiated May 4, 2005

    Recall

    Recall Number
    Z-1087-05
    Event Number
    31969
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2005
    Posted
    August 6, 2005
    Terminated
    July 21, 2006
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico

    Reason

    The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.

    Action

    Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.

    Distribution

    Nationwide and internationally to Australia, Belgium, Canada and Japan.

    Quantity

    13,229 units