BEUDAMED
    FDA Recall Terminated

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    Recall: Z-0639-2016 · Initiated October 22, 2015

    Recall

    Recall Number
    Z-0639-2016
    Event Number
    72540
    Firm
    Mercury Enterprises, Inc. dba Mercury Medical
    FEI Number
    1024404
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 22, 2015
    Terminated
    October 13, 2017
    Address
    11300 49th St N, Clearwater, FL, 33762-4807

    Description

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    Reason

    Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

    Action

    Mercury Medical sent notification letters dated October 22, 2015, to all affected Domestic Consignees by courier and for the foreign consignees the notifications were sent via e-mail. The letter identified the product, the problem, and the action to be taken by the consignee. Customer Immediate Actions - Immediately notify all personnel subject to using these devices to remove protective cap before connecting a mask. Further this filed safety advisory notice should be read in conjuction with the manufacturer supplied instructions for use. In addition, if you further distributed this product, please identify your customers and notify them at once of this product correction. Notificatin to your customers should include a copy of this letter. For questions contact Mercury Medical at 787-573-0088, 727-573-4966 fax or via e-mail at [email protected]

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirate, and United Kingdom..

    Quantity

    753,245 devices