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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

FDA Recall Z-0639-2016 · Posted None

Recall StatusTerminated
Product CodeBTL
Date Initiated2015-10-22
Date Terminated2017-10-13
Product Quantity753,245 devices

Reason for Recall

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

Firm 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]

Root Cause

Device Design

Distribution Pattern

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..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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