BEUDAMED
    FDA Recall Terminated

    Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 25 DESCRIPTION: ADJUSTABLE VENT VALVE, STERILE The TruChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.

    Recall: Z-3058-2011 · Initiated July 21, 2011

    Recall

    Recall Number
    Z-3058-2011
    Event Number
    59524
    Firm
    Alliant Enterprises LLC
    FEI Number
    3004986960
    Product Code
    MJJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2011
    Posted
    August 23, 2011
    Terminated
    April 23, 2012
    Address
    8850 M 89, Richland, MI, 49083-8558

    Description

    Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 25 DESCRIPTION: ADJUSTABLE VENT VALVE, STERILE The TruChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.

    Reason

    The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together.

    Action

    Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.

    Distribution

    Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea

    Quantity

    153 Boxes of 25