BEUDAMED
    FDA Recall Terminated

    Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

    Recall: Z-0694-05 · Initiated January 20, 2005

    Recall

    Recall Number
    Z-0694-05
    Event Number
    31019
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2005
    Posted
    April 8, 2005
    Terminated
    April 14, 2006
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

    Reason

    Product older than three years may not operate as intended.

    Action

    Urgent Product Recall letters dated 1/20/05 were sent to the direct accounts via first class mail, to the attention of the Director of Purchasing. The accounts were informed that the Posiflow Luer Activated valves may not operate as intended if the product is older than three years. The accounts were instructed to examine their inventories of the affected product codes listed to determine if they have any product on hand without expiration dating, and remove any found from inventory. The expiration date, if present, may be found on both the individual product package and on the end panel label of the product shipping carton. The accounts were instructed to call Baxter at 1-888-229-0001 to arrange for the return of any product found without an expiration date. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

    Distribution

    Nationwide, including American Samoa, and internationally to Venezuela.

    Quantity

    1,585,542 units