BEUDAMED
    FDA Recall Terminated

    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

    Recall: Z-0559-2014 · Initiated September 27, 2013

    Recall

    Recall Number
    Z-0559-2014
    Event Number
    66535
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 27, 2013
    Posted
    December 21, 2013
    Terminated
    October 8, 2014
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

    Reason

    One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

    Action

    B. Braun sent an Urgent Medical Device Recall Notification letter dated September 27, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to utilize the attached "Product Removal Acknowledgement Form" to record the number of individual units in their inventory and fax the completed form to 610-848-1197. To ensure proper credit for affected product, customers were instructed to return the product to B. Braun Medical Inc. For questions contact Customer Support Department at 800-227-2862.

    Distribution

    USA Nationwide Distribution including Puerto Rico.

    Quantity

    55,200 units