BEUDAMED
    FDA Recall Terminated

    CIDEX OPA Solution, ortho-Phthalaldehyde Solution

    Recall: Z-0051-05 · Initiated April 12, 2004

    Recall

    Recall Number
    Z-0051-05
    Event Number
    29903
    Firm
    Advanced Sterilization Products
    FEI Number
    3003662624
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2004
    Posted
    October 28, 2004
    Terminated
    September 2, 2005
    Address
    33 Technology Dr, Irvine, CA, 92618-2346

    Description

    CIDEX OPA Solution, ortho-Phthalaldehyde Solution

    Reason

    Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.

    Action

    Firm conducted WebEx meeting with affiliates on April 12 & 13, 2004 to discuss CIDEX OPA Solution labeling. April 23, 2004, Firm sent letters to affiliates, customers, and end users to notify of new contraindication for CIDEX OPA Solution. Same letter was sent to U.S. Healthcare facilities on April 23, 2004; to Urology M.D.s on April 28, 2004; to Urologist Nurses on May 7, 2004. Customers can call 800-370-4632 with questions.

    Distribution

    Worldwide