BEUDAMED
    FDA Recall Terminated

    CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case

    Recall: Z-0177-04 · Initiated October 30, 2003

    Recall

    Recall Number
    Z-0177-04
    Event Number
    27605
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 30, 2003
    Posted
    December 4, 2003
    Terminated
    April 13, 2005
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case

    Reason

    Use of the dialyzers may cause iritis (red-eye) patient reactions.

    Action

    Recall letters dated October 30, 2003 informed the customers of the patient reactions and were provided with copies of the December 16, 1996 letter from the FDA, 'Important Information Relating to Cellulose Acetate Dialyzers'. The accounts were requested to examine their inventories for the affected lots and discontinue their use immediately.

    Distribution

    Nationwide, Mexico, Chile, Ecuador, Argentina, Puerto Rico and Brazil.

    Quantity

    34,865 units