BEUDAMED
    FDA Recall Terminated

    Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.

    Recall: Z-2248-2011 · Initiated April 7, 2011

    Recall

    Recall Number
    Z-2248-2011
    Event Number
    58471
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    April 7, 2011
    Posted
    May 26, 2011
    Terminated
    March 14, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.

    Reason

    Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.

    Action

    The firm, Philips, sent a Field Safety Notice titled "URGENT MEDICAL DEVICE RECALL" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the "Action to be taken by Customer/User" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.

    Distribution

    Worldwide distribution.

    Quantity

    75 units (3 boxes)