Recall Z-0639-2016— Mercury Enterprises, Inc. dba Mercury Medical
Class II · Terminated
Class II FDA medical device recall by Mercury Enterprises, Inc. dba Mercury Medical, initiated 2015-10-22, terminated 2017-10-13. It names one FDA 510(k) clearance: K093913. Product: 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..
- Recalling firm
- Mercury Enterprises, Inc. dba Mercury Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-22
- Terminated
- 2017-10-13
- Firm location
- Clearwater, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.