BEUDAMED
    FDA Recall Terminated

    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    Recall: Z-1063-2016 · Initiated February 10, 2016

    Recall

    Recall Number
    Z-1063-2016
    Event Number
    73266
    Firm
    Arrow International, Inc., Division of Teleflex Medical Inc.
    FEI Number
    3010532612
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 10, 2016
    Posted
    March 11, 2016
    Terminated
    May 12, 2021
    Address
    9 Plymouth St, Everett, MA, 02149-1814

    Description

    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    Reason

    The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

    Action

    The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

    Quantity

    13,405 US and 33,735 OUS in total