FDA Device recall Z-0639-2016
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit by Mercury Enterprises, citing incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0639-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-22 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mercury Enterprises |
| Distribution | US |
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.
Identifiers
| code_info | Neo-Tee Resuscitator: Part # 1050800 Unique Device ID # 10641043508004 Lot #s less than 1528850800; Part # 1050801 Uni…Neo-Tee Resuscitator: Part # 1050800 Unique Device ID # 10641043508004 Lot #s less than 1528850800; Part # 1050801 Unique Device ID # 10641043508015 Lot #s less than 1528850801;Part # 1050802 Unique Device ID # 10641043508022 Lot #s less than 1528850802; Part # 1050803 Unique Device ID # 10641043508039 Lot #s less than 1528850803; Part # 1050804 Unique Device ID # 10641043508046 Lot #s less than 1528850804; Part # 1050805 Unique Device ID # 10641043508053 Lot #s less than 1528850805; Part # 1050806 Unique Device ID # 10641043508060 Lot #s less than 1528850806; Part # 1050807 Unique Device ID # 10641043508077 Lot #s less than 1528850807; Part # 1050808 Unique Device ID # 10641043508084 Lot #s less than 1528850808; Part # 1050809 Unique Device ID # 10641043508091 Lot #s less than 1528850809; Part # 1050810 Unique Device ID # 10641043508107 Lot #s less than 1528850810; Part # 1050811 Unique Device ID # 10641043508114 Lot #s less than 1528850811; Part # 1050812 Unique Device ID # 1064 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0639-2016%22
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