BEUDAMED
    FDA Recall Terminated

    AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

    Recall: Z-0983-2019 · Initiated January 24, 2019

    Recall

    Recall Number
    Z-0983-2019
    Event Number
    82090
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 24, 2019
    Terminated
    July 13, 2020
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

    Reason

    Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

    Action

    The firm, Maquet/Getinge, issued "URGENT MEDICAL DEVICE RECALL - REMOVAL" letters mailed to customers on January 24, 2019 via FedEx Priority Overnight,. The letters identified the issue, the product, actions to take and health risk. The customers were instructed to:Please examine your inventory immediately to determine if you have any of the affected; stop using the affected lot numbers of the Axius Blower Mister; remove and properly label any identified affected product, and keep it in quarantine in a secure location to preclude being used. Should you have un-used affected product you are eligible for either a replacement or credit. Please contact Geting Customer Service at 1-888-627-8383 (press option 2, then option 4) to request a return authorization (RMA) and shipping instructions to return any affected product. Complete and sign the MEDICAL DEVICE RECALL - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to blowermister(@qetinge.com or by faxing the form to 1-800-915-0124. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 4), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.

    Distribution

    Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

    Quantity

    7,880 each (1,576 packs of 5)