BEUDAMED
    FDA Recall Terminated

    Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.

    Recall: Z-1529-2010 · Initiated February 15, 2010

    Recall

    Recall Number
    Z-1529-2010
    Event Number
    55016
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 15, 2010
    Posted
    April 29, 2010
    Terminated
    January 29, 2012
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.

    Reason

    Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product.

    Action

    Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303.

    Distribution

    United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia

    Quantity

    64,560 units