BEUDAMED
    FDA Recall Terminated

    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    Recall: Z-0170-2013 · Initiated July 11, 2012

    Recall

    Recall Number
    Z-0170-2013
    Event Number
    63347
    Firm
    Ventlab Corporation
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 11, 2012
    Posted
    November 1, 2012
    Terminated
    June 30, 2013
    Address
    155 Boyce Dr, Mocksville, NC, 27028-4187

    Description

    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    Reason

    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

    Action

    VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to [email protected]. For questions regarding this recall call 336-753-5000.

    Distribution

    Nationwide Distribution including IL, OH, NY and TN.

    Quantity

    14,602 total for all units