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U.S. Department of Health and Human Services

Safety

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Hospitak Airway Adapter

Audience: Respiratory healthcare professionals, risk managers, and home health care workers

[December 2, 2004] Unomedical, Inc. issued a public safety alert regarding their Hospitak brand 22 mm /15 mm airway adapter (Ref 962-E) distributed by Unomedical Inc., McAllen, Texas. Several adapters were found to be blocked or occluded, potentially preventing exhalation or inhalation. This could result in serious or life-threatening injury to patients. These adapters are used as accessories in a wide variety of respiratory applications, including extending breathing circuits and attaching reservoir bags. Although this product is primarily distributed to medical institutions, some units could be distributed for home use.

[UPDATE December 23, 2004] On December 2, 2004, the original November 30, 2004 recall notice for two lots of Unomedical's Hospitak airway adapters was expanded to a nationwide warning/recall to include additional Hospitak lots and adapters sold by Viasys, Dräger, and Unomedical. Patients and medical health professionals who have Hospitak, Viasys, Unomedical, Bio-Med Devices and/or Dräger brand airway adapters should check with Unomedical, Inc. before using the product. Patients and health care institutions who are not sure of the origin of the airway adapters they have in stock may want to check with their suppliers to make sure that they are not affected by this recall. (SEE Bio-Med safety summary)

[November 30, 2004 - Press Release - Unomedical, Inc.]