Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which carries a minimum severity rating of 4. The defect affects a critical emergency respiratory support device for pediatric patients, where failure to maintain proper pressure ranges could result in inadequate ventilation. Although no injuries or deaths have been reported, the documented malfunction of essential emergency equipment warrants a Severe classification.
Plain-English summary
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator, an emergency respiratory support device for pediatric patients, due to a manufacturing defect in the circuit flow controller.
The device's flow controller was manufactured with an undersized spring, which may prevent the resuscitator from reaching the full range of positive end-expiratory pressure (PEEP) and positive inspiratory pressure (PIP) settings. This failure could result in loss of positive pressure and impaired ventilation of the patient.
The affected resuscitators total 37,370 units across multiple part numbers and lot codes. They have been distributed nationwide in the United States and internationally to Canada, the United Kingdom, France, Spain, Italy, Netherlands, Switzerland, Hungary, United Arab Emirates, Saudi Arabia, and Hong Kong.
Healthcare providers using these devices should contact Mercury Medical for information about replacement units or remediation options.
The recalled product
- Product
- Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
- Manufacturer
- Mercury Enterprises, Inc. dba Mercury Medical
- Affected units
- 37,370
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/UDI-DI/Lot: 1050805/10641043508053
- 30641043508057/2421450805
- 2423550805
- 2423650805
- 2426750805
- 1050808/10641043508084
- 30641043508088/2426450808
- 2426750808
- 2426850808
- 2429050808
- 2429350808
- 1050809/10641043508091
- 30641043508095/2426450809
- 2426750809
- 2429050809
- 2429150809
- 2429350809
- 2429750809
- 2429850809
- 2430050809
Distribution
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