As reported by the FDA, Mercury Medical has issued a Class I recall of their Neo-Tee T-Piece Resuscitators due to a potential malfunction with the inline controller. The company warns that continued use of the product could cause serious injury up to and including death.
The Neo-Tee T-Piece Resuscitator is a device used to provide emergency resuscitation to newborns and babies weighing under 22 pounds. The device uses compressed gas to deliver breaths via a face mask to an infant with compromised breathing. Mercury Medical announced the recall upon finding that the inline controller has a tendency to “come apart” while in use. When this happens, air flow to the patient is interrupted. While Mercury Medical has not received any reports of injury, they say that use of the Neo-Tee T-Piece Resuscitator “may cause serious adverse health consequences, including injury from lack of oxygen (ischemia) and death.”
Mercury Medical notified health care facilities and distributors of the recall on September 4, 2004. The recall applies to four lots of the Neo-Tee T-Piece Resuscitators, with the following Lot and UDI numbers: 2417650805 (UDI 10641043508053), 2417750805 (UDI 30641043508057), 2423550832 (UDI 10641043508329), and 2417850832 (UDI 30641043508323). The company also listed Part Numbers for the affected devices as 1050805 and 1050832.
In an urgent notice, the company asked health care facilities to locate and quarantine all Neo-Tee T-Piece Resuscitators that meet the recall criteria. Distributors were asked to cease distribution of the product immediately. Both health care facilities and distributors were urged to contact Mercury Medical’s customer service department at uscustomerservice@mercurymed.com for guidance on returning the product.
Anyone in the United States with questions about the recall can contact their Mercury Medical sales representative or the Mercury Medical team at 800-237-6418 or 727-573-0088. Alternately, Mercury Medical can be reached via email at regulatoryaffairs@mercurymed.com.
Patients and health care providers can report any new adverse health events related to the Neo-Tee T-Piece Resuscitator through the FDA’s MedWatch Online Voluntary Reporting Form.
If your child has suffered an adverse health outcome caused by the Neo-Tee T-Piece Resuscitator, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent further injury to patients receiving emergency resuscitation. Our experienced attorneys at TruLaw are prepared to learn about your story and help you build a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.