Mercury Medical Issues Recall for Neo-Tee Resuscitators: Important Information
This recall pertains to the removal of specific devices from use or sale. The FDA has classified this recall as a serious matter, given that the device in question could lead to severe injury or even death if it remains in use.
Product Details
- Product Name: Neo-Tee T-Piece Resuscitator with Manometer and Controller with Pressure Relief Valve
| Part Number | Unique Device ID | Description | Lot Number |
|---|---|---|---|
| 1050805 | 10641043508053 30641043508057 |
Neo-Tee Resuscitator | 2417650805 2417750805 |
| 1050832 | 10641043508329 30641043508323 |
Neo-Tee Resuscitator | 2423550832 2417850832 |
Recommended Actions
- Affected product should not be used.
On September 4, 2024, Mercury Medical communicated with all impacted clients through an Urgent Field Safety Notice outlining the following measures:
For Medical Facilities
- Verify inventory for products subject to this recall immediately.
- Cease the use and distribution of the impacted products.
- Isolate the affected products.
- Reach out to customer service at uscustomerservice@mercurymed.com for assistance in returning the referenced products for either replacement or credit.
For Distributors
- Disseminate this recall information to all customers who obtained the affected products.
- Ensure each customer completes and returns the acknowledgment form.
- Contact customer service at uscustomerservice@mercurymed.com to facilitate the return of affected products for replacement or credit.
Cause for the Recall
The recall of the Neo-Tee Resuscitators by Mercury Medical is initiated due to risks associated with the inline controller potentially disassembling, which could compromise positive pressure, thereby affecting the patient’s ventilation and rendering the inline controller unusable. U.S. clients with inquiries regarding this recall should get in touch with their Mercury Medical sales representative or contact the Mercury Medical team at 800-237-6418/727-573-0088 or via email at regulatoryaffairs@mercurymed.com.
Utilizing the impacted product poses serious health risks, including potential oxygen deprivation leading to ischemia and death.
No injuries or fatalities related to the recall have been reported thus far.
Product Application
The Neo-Tee T-Piece Resuscitator is a gas-driven emergency support device designed to provide immediate breathing assistance via a mask or airway tube. This device is specifically designed for neonates and infants weighing below 22 lbs.
Customer Support
For any concerns relating to this recall, U.S. customers should consult their Mercury Medical sales representative or connect with the Mercury Medical support team at 800-237-6418/727-573-0088 or email regulatoryaffairs@mercurymed.com.
FDA Information Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) serves as a means to track individual medical devices sold within the U.S., covering the entire spectrum from manufacturing to distribution and patient usage. The UDI enhances the accuracy of reporting, assessing, and analyzing adverse event reports, facilitating quicker identification and resolution of device-related problems.
How to Report Issues
Healthcare providers and consumers are encouraged to report any adverse reactions or quality issues linked to these devices using MedWatch: The FDA Safety Information and Adverse Event Reporting Program.