BEUDAMED
    FDA Recall Terminated

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    Recall: Z-1058-2013 · Initiated September 12, 2011

    Recall

    Recall Number
    Z-1058-2013
    Event Number
    64751
    Firm
    Engineered Medical Systems, Inc
    FEI Number
    1832562
    Product Code
    BSJ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 12, 2011
    Posted
    April 10, 2013
    Terminated
    August 2, 2013
    Address
    2055 Executive Drive, Indianapolis, IN, 46241-4311

    Description

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    Reason

    The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

    Action

    Consignees were notified 9/12/2011 with a Medical Device Voluntary Recall letter identifying the product and the problem. Consignees were directed to quarantine, cease further distribution, and destroy the affected product, returning a proof of confirmation/disposal letter, to be submitted for credit. Correspondence should be sent to Tamara Lefevers, Quality Manager, at tlefevers@ engmedsys.com or fax 317-246-5501.

    Distribution

    Distributed in the states of PA, IN, NY, CO, and CA.

    Quantity

    1500pcs, 75cs {20pcs per cases)