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U.S. Department of Health and Human Services

Medical Devices

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BioMed Unomedical Airway Adapter

Class I Recall
Date Recall
Initiated:

December 2, 2004

 

Product:

Unomedical Hospitak brand 22 mm/15 mm airway adapter. The potentially affected lots are 04-40, dated 2004 09 and 04-41, dated 2004 10.

 

Use:

This product is used as an accessory connector typically for extending the airway circuits and attaching various breathing circuit components, e.g. reservoir bags. Although this product is primarily distributed to medical facilities, some units could be distributed for home use.

 

Recalling Firm:

Unomedical Inc.
6001 S 35th Street
McAllen, Texas 78503-8887

 

Reason for Recall:

Adapters were found to be blocked or occluded, potentially preventing exhalation or inhalation.

 

Public Contact:

Erik Nissen
1-800-634-6003

 

FDA District:

Dallas

 

FDA Comment:

Medical health professionals who have these Hospitak adapters should check with Unomedical before using the product to make sure it is not occluded. Additionally, some of the affected products have been labeled and sold under the Viasys, Unomedical and Drager brand name. Users should consult the attached press release for the total list of affected products and lot numbers.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

 

 

For additional information on this product recall, see the FDA press release.

Also, for additional information on this product recall, see the FDA Enforcement Report.