ResMed Masks, Busse Sterile Trays, Fresenius Infusion Pumps Classified as Class I

The agency deemed ResMed’s recall of its continuous positive airway pressure (CPAP) masks with magnets on the lower headgear straps and frame connections because of the potential for magnetic interference when used with certain medical devices.

In another recall deemed Class I by the FDA, Fresenius Kabi is recalling its Ivenix Large Volume Pump because mechanical issues in certain units may cause the product’s fluid valve pins fail to move improperly, resulting in a failure alarm to sound and the device to cease the infusion.

Also receiving a Class I recall designation are Busse Hospital Disposal’s tracheostomy care tray, dressing change tray and tracheostomy care set. The producer of the saline used in Busse’s products, Texas-based Nurse Assist, recalled its 0.9 percent sodium chloride irrigation USP and sterile water for irrigation USP in November 2023 over sterility concerns.

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