Unomedical, Inc. issued a safety alert regarding its Hospitak brand 22-millimeter and 15-millimeter airway adapters. The adapters are used as accessories in a variety of respiratory applications, primarily in medical institutions, but possibly also distributed for home use, according to the Food and Drug Administration (FDA).
Several Hospitak adapters were reported blocked and able to cause serious or life-threatening injury to patients. If the adapters are blocked or occluded, exhalation or inhalation could be prevented. One serious injury has been reported.
The two lots initially determined to be potentially affected by the problem are lot 04-40, dated 2004 09, and lot 04-41, dated 2004 10. The package labeling has the Hospitak brand name on it, as well as "REF 962-E".
The FDA issued a report on December 2, 2004 to say that “Subsequent investigation by Unomedical indicates that other lots of the product, including airway adaptors used in other medical devices, may have been affected. Some of the affected products have been labeled and sold under the Viasys, Unomedical, and Dräger brand name…Patients and medical health professionals who have Hospitak, Viasys, Unomedical, and/or Dräger brand airway adapters should check with Unomedical, Inc. before using the product.”