A Medical Device Daily
Unomedical (McAllen, Texas) reported that it has expanded its warning and has begun a recall of airway adapters it distributed in the U.S. and Europe. Several adapters have been found to be blocked or occluded, preventing exhalation or inhalation, thus potentially resulting in serious or life-threatening injury.
One serious patient injury has been reported to date.
In a public alert issued in late November (Medical Device Daily, Dec. 3, 2004), Unomedical warned that at least two lots of its Hospitak brand 22 mm/15 mm adapters may have been affected by the problem. The product is primarily distributed to medical institutions, with some units also distributed for home use.
The adapters are used in a variety of respiratory applications, such as extending breathing circuits and attaching reservoir bags.
The company said that “subsequent investigation . . . 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 Dr ger brand names. Overall, about 17 lot numbers are affected.
Patients and medical health professionals who have Hospitak, Viasys, Unomedical or Dr ger brand airway adapters have been advised to check with the company before using the product. Patients and healthcare institutions that are not sure of the origin of the airway adapters they have in stock were advised to check with their suppliers to make sure that they are not affected by this recall.