Neo-Tee T-Piece Resuscitator (Mercury Medical) – Flow Controller Defect (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

Recommended Action

Per FDA guidance

On 12/10/2024, "URGENT: FIELD SAFETY NOTICE" letters were mailed and emailed to medical facilities and distributors who were asked to do the following: Medical Facilities/Distributors: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Contact firm's customer service department at uscustomerservice@mercurymed.com (Domestic) and InternationalCustomerService@mercurymed.com (International) to assist you on how to send the affected product back to the firm for product replacement or credit. 3) Please notify all personnel subject to using these devices. 4) Complete and return the response form via email to regulatoryaffairs@mercurymed.com In addition, distributors were asked to do the following: 5) Provide a copy of this recall notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. If you have any questions regarding this action, contact the firm at 800-237-6418/727-573-0088, or e-mail at regulatoryaffairs@mercurymed.com