Mallinckrodt Manufacturing LLC is recalling its one-way valve, 22F x 22M, a single-use system accent used to forestall backward move of nitric oxide fuel into the airways, on account of units not opening correctly, which prevents or reduces the move of ventilated air or oxygen.
Using the one-way valve, 22F x 22M could trigger severe adversarial well being penalties, together with interruption in air flow which can delay supply of nitric oxide fuel, in keeping with a security discover from the US Meals and Drug Administration. This delay might result in bradycardia in neonatal or pediatric sufferers. For all sufferers, interruption in air flow could result in inadequate oxygen within the blood leading to respiratory failure and dying.
There have been two complaints and no studies of accidents or dying.
The US Meals and Drug Administration has recognized this as a Class I recall, essentially the most severe kind of recall.
- Product names: One-way valve, 22F x 22M
- Product codes: See recall database entry
- Mannequin numbers:
- Distribution dates: Jan 26, 2022, to July 27
- Gadgets recalled within the US: 1,799 units in packs of 5
- Date initiated by agency: July 28
The Mallinckrodt Manufacturing one-way valve, 22F x 22M is a part of the INOmax supply system, which delivers nitric oxide (INOmax) remedy fuel into the tubes between the ventilator and affected person airway (respiratory circuit). The one-way valve is used to forestall backward move of nitric oxide fuel into the INOmax DSIR injector module. The omission of one-way valve may end in excessive nitric oxide supply to the affected person. The meant prevention of the backward move and higher-than-prescribed drug supply applies to each high-frequency ventilators and spontaneous masks setup.
On Aug 8, Mallinckrodt Manufacturing despatched all affected clients an Necessary Medical System Advisory.
The letter requested clients to:
- Decide in case your facility has any of the impacted tons.
- Return solely the one-way valves from the affected lot numbers to Mallinckrodt Manufacturing. Use the enclosed FedEx Label to return the one-way valve(s) and the Buyer Response Kind.
- Ship the Buyer Response Kind to produc[email protected] even when your facility has no product to return.
If a one-way valve from an affected lot is at the moment in use on a affected person and dealing as anticipated, Mallinckrodt Manufacturing instructs clients to not take away it from the circuit and proceed to observe the affected person’s oxygen saturation ranges.
Well being care professionals and customers could report adversarial reactions or high quality issues they skilled utilizing these units to MedWatch: The FDA Security Info and Opposed Occasion Reporting Program utilizing an internet kind, common mail, or fax.