BEUDAMED
    FDA Recall Terminated

    Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit

    Recall: Z-1012-2011 · Initiated November 11, 2010

    Recall

    Recall Number
    Z-1012-2011
    Event Number
    57259
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 11, 2010
    Posted
    February 1, 2011
    Terminated
    July 5, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit

    Reason

    Sterility may be compromised.

    Action

    The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.

    Distribution

    Nationwide Distribution: USA states including IL and LA.

    Quantity

    2320