Unomedical, Inc. Issues Nationwide Public Safety Alert on Hospitak Airway AdapterNov 30, 2004 | ww.fda.gov
Unomedical, Inc. has issued a public safety alert regarding their Hospitak brand 22 mm /15mm airway adapter (Ref 962-E) distributed by Unomedical Inc., McAllen, Texas, because of safety concerns. The product is labeled as being manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico. Several adapters have been found to be blocked or occlude, potentially preventing exhalation or inhalation. This could result in serious or life-threatening injury to patients
To date one serious patient injury has been reported.
Although this product is primarily distributed to medical institutions, some units could be distributed for home use. These adapters are used as accessories in a wide variety of respiratory applications, for example: extending breathing circuits and attaching reservoir bags.
Hospitak brand 22 mm /15mm adapters were distributed to hospital and home health care supply distributors nationwide. Two lots have been identified as being potentially affected by the problem so far:
* Lot 04-40, dated 2004 09
* Lot 04-41, dated 2004 10
This investigation is continuing and other lot numbers may be involved. The adapter's package labeling can be identified by the Hospitak brand name and "REF 962-E." Patients and medical health professionals who have Hospitak adapters should check with Unomedical, Inc. before using the product to make sure it is not occluded. Unomedical can be reached at 1 800 634 6003. Those who have other questions or concerns may also contact their local FDA office. Unomedical, Inc. is working in cooperation with the FDA.