The Recall Desk
HighFDA (Devices)·Z-0639-2016·Announced 2016-01-20

Mercury Medical Recalls Neo-Tee T-Piece Resuscitators Due to Occlusion Risk

Mercury Medical is recalling Neo-Tee T-Piece Resuscitators and circuits because incorrect use can cause complete circuit occlusion, leading to failure to ventilate the patient.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (failure to ventilate) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Mercury Enterprises, Inc. dba Mercury Medical is recalling the 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 to neonates and infants weighing less than 10kg (22 lb) via a face mask or airway tube. The T-piece resuscitator circuit is a component used in conjunction with these devices.

The recall is due to a risk that incorrect use of the T-Piece resuscitators will result in complete occlusion of the patient circuit. This occlusion can cause a failure to ventilate the patient. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Approximately 753,245 devices are affected by this recall. The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Australia, Canada, China, Germany, Japan, and the United Kingdom. Affected units include specific part numbers and lot numbers less than 1528850800 through 1528850830 for the resuscitators, and specific part numbers and lot numbers less than 1528850900 through 1528850914 for the circuits. Consumers and healthcare facilities should check their inventory against the specific part and lot numbers provided in the official recall notice.

The recalled product

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
Manufacturer
Mercury Enterprises, Inc. dba Mercury Medical
Category
Medical Device — Respiratory Support
Hazard
Affected units
753,245

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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 # 10641043508121 Lot #s less than 1528850813
  • Part # 10508138 Unique Device ID # 10641043508004 Lot #s less than 1528850813
  • Part # 1050814 Unique Device ID # 106410435081454 Lot #s less than 1528850814
  • Part # 1050815 Unique Device ID # 10641043508152 Lot #s less than 1528850815
  • Part # 1050816 Unique Device ID # 10641043508169 Lot #s less than 1528850816
  • Part # 1050817 Unique Device ID # 10641043508176 Lot #s less than 1528850817
  • Part # 1050818 Unique Device ID # 10641043508183 Lot #s less than 1528850818
  • Part # 1050819 Unique Device ID # 10641043508190 Lot #s less than 1528850819
  • Part # 1050820 Unique Device ID # 10641043508206 Lot #s less than 1528850820

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · Mercury Enterprises, Inc. dba Mercury Medical

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