Unomedical Inc. issued a recall Thursday on airway adapters distributed in the United States and Europe, saying several have been blocked and could cause serious or life-threatening injury to patients. One serious injury has been reported.
The adapters are used as accessories in a variety of respiratory applications. If they are blocked or occluded, exhalation or inhalation could be prevented, the company said.
A safety alert that was issued earlier this week, listing two Hospitak lot numbers for the 22-millimeter/15-millimeter adapters, was extended after investigation. The recall includes other lots of the product, including adapters used in other devices. Some of the products have been labeled and sold under the names Viasys, Unomedical and Drager.
Unomedical said patients and health care providers using Hospitak, Viasys, Unomedical or Drager airway adapters should check with Unomedical at 1-800-634-6003. Unomedical said it is working with the FDA, and people with further questions could contact their local FDA office for more information.