September 11, 2023
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: One-Way Valve, 22F x 22M
- Product Codes: See Recall Database Entry
- Model Numbers:
- Distribution Dates: January 26, 2022 to July 27, 2023
- Devices Recalled in the U.S.: 1,799 devices in packs of five
- Date Initiated by Firm: July 28, 2023
The Mallinckrodt Manufacturing, LLC One-Way Valve, 22F x 22M is part of the INOmax Delivery System, which delivers nitric oxide (INOmax) therapy gas into the tubes between the ventilator and patient airway (breathing circuit). The One-Way Valve is used to prevent backward flow of nitric oxide gas into the INOmax DSIR injector module. The omission of One-Way Valve can also result in high nitric oxide delivery to the patient. The intended prevention of the backward flow and higher than prescribed drug delivery applies to both high frequency ventilators and spontaneous mask setup.
Reason for Recall
Mallinckrodt is recalling its One-Way Valve, 22F x 22M due to devices not opening properly, which prevents or reduces the flow of ventilated air or oxygen.
The use of the One-Way Valve, 22F x 22M may cause serious adverse health consequences, including interruption in ventilation which may delay delivery of nitric oxide gas. This delay could lead to bradycardia in neonatal or pediatric patients. For all patients, interruption in ventilation may lead to insufficient oxygen in the blood resulting in respiratory failure, and death.
There have been two complaints, and no reports of injuries or death.
Who May be Affected
- People who receive respiratory support using a Mallinckrodt One-Way Valve, 22F x 22M
- Health care personnel providing care that includes the Mallinckrodt One-Way Valve, 22F x 22M
What to Do
On August 8, 2022, Mallinckrodt Manufacturing, LLC sent all affected customers an Important Medical Device Advisory.
The letter requested customers to:
- Determine if your facility has any of the impacted lots.
- Return only the One-Way Valves from the affected lot numbers to Mallinckrodt Manufacturing, LLC. Use the enclosed FedEx Label to return the One-Way Valve(s) and the Customer Response Form.
- Send the Customer Response Form to [email protected] even if your facility has no product to return.
If a One-Way Valve from an affected lot is currently in use on a patient and working as expected, please do not remove it from the circuit and continue to monitor the patient’s oxygen saturation levels.
Customers in the U.S. with questions about this recall should contact Mallinckrodt Customer Care at: 1(877)-566-9466.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.