BEUDAMED
    FDA Recall Terminated

    Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system

    Recall: Z-2048-2011 · Initiated March 25, 2011

    Recall

    Recall Number
    Z-2048-2011
    Event Number
    58331
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2011
    Terminated
    January 29, 2014
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system

    Reason

    Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.

    Action

    The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.

    Distribution

    Nationwide distribution: USA including states of: PA and NJ.

    Quantity

    840