Recall Z-0639-2016 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Mercury Enterprises, Inc. dba Mercury Medical
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 conju
| Date | Oct 22, 2015 |
| Status | Terminated |
| Reason | Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. |
| Root cause | Device Design |
| 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 produ |
| Quantity | 753,245 devices |
| 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, Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR Mercury Medical, Inc., Apr 6, 2010 |