BEUDAMED
    FDA Recall Terminated

    Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.

    Recall: Z-1033-2012 · Initiated February 3, 2012

    Recall

    Recall Number
    Z-1033-2012
    Event Number
    61129
    Firm
    Ventus Medical, Inc.
    FEI Number
    3007038487
    Product Code
    OHP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 3, 2012
    Posted
    February 15, 2012
    Terminated
    February 15, 2012
    Address
    1301 Shoreway Rd, Ste 425, Belmont, CA, 94002-4154

    Description

    Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.

    Reason

    A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.

    Action

    Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.

    Distribution

    Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.

    Quantity

    288 units