Neo-Tee T-Piece Resuscitator circuit flow controller may come apart
Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This device has an FDA Class I classification, which establishes a minimum severity threshold of 4. Although no deaths or reported serious injuries are documented in the source, the defect in a pediatric emergency respiratory device poses significant potential risk of harm.
Plain-English summary
Mercury Enterprises, Inc. dba Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators (Part Numbers 1050805 and 1050832) used for pediatric emergency respiratory support. The recall is due to a manufacturing defect: the circuit flow controller may come apart because of a missing step in the manufacturing process.
The recalled units were distributed in the United States to Michigan, Florida, South Carolina, Pennsylvania, and Indiana, as well as internationally to Albania. Affected lot numbers include 2417650805 and 2417750805 (Part Number 1050805), and 2423550832 and 2417850832 (Part Number 1050832).
Healthcare facilities and providers who have received these devices should stop using affected units immediately and contact Mercury Medical for device replacement or repair instructions. For additional information, refer to FDA recall number Z-0004-2025.
The recalled product
- Product
- Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
- Manufacturer
- Mercury Enterprises, Inc. dba Mercury Medical
- Hazard
- assembly-defect
- device-malfunction
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 (9)
- Part Number: 1050805
- UDI/DI: 10641043508053
- 30641043508057
- Lot Numbers: 2417650805
- 2417750805. Part Number: 1050832
- UDI/DI: 10641043508329
- 30641043508323
- Lot Numbers: 2423550832
- 2417850832.
Distribution
Distributed in 5 states:
- FL
- IN
- MI
- PA
- SC
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