BEUDAMED
    FDA Recall Terminated

    Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23.

    Recall: Z-1736-2009 · Initiated June 16, 2009

    Recall

    Recall Number
    Z-1736-2009
    Event Number
    52452
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 16, 2009
    Posted
    August 19, 2009
    Terminated
    October 27, 2010
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23.

    Reason

    The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

    Action

    Stryker Instruments issued a recall letter dated June 16, 2009 and instructed Consignees to cease using and destroy the product and to return a business reply form for credit via fax to Stryker Instruments Regulatory Department, 1-866-521-2762. For further questions, contact Stryker Instruments at 1-800-800-4236 extension 3808.

    Distribution

    Worldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan.

    Quantity

    268