Unomedical issues safety alert for some airway adapters
Tuesday, November 30th 2004, 11:22 am
By: News On 6
WASHINGTON (AP) _ Unomedical, Inc. issued a safety alert Tuesday about its Hospitak airway adapters, saying several have been blocked and could possibly 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.
The Hospitak brand 22mm/15mm adapters, distributed by Unomedical of McAllen, Texas, were assembled in Mexico and distributed nationwide. The Food and Drug Administration said some were shipped to Malaysia.
The adapters are used primarily in medical institutions, but some units could have been distributed for home use, the FDA said. The agency is still investigating.
The two lots potentially affected by the problem are lot 04-40, dated 2004 09, and lot 04-41, dated 2004 10. The company said other numbers also may be involved.
The package labeling has the Hospitak brand name on it, as well as ``REF 962-E.''
Unomedical said that patients and health care providers using Hospitak adapters should check with Unomedical at 1-800-634-6003 before using the product. Unomedical said it is working with the FDA, and people with further questions could also contact their local FDA office for more information.