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U.S. Department of Health and Human Services

Safety

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Bio-Med Patient Tubing Assembly with Adaptor

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

Bio-Med Devices Inc. is voluntarily recalling Patient Breathing Circuits with Catalog Numbers: 80011, 80015, 8002A, 8002A-7, 8002A-9, DENTL, 3030-5, 4408 (built between September 22, 2004 and December 2, 2004). The device contains a 22mm x 22mm adapter made, and recalled, by Unomedical, who has found a potential blockage problem which could contribute to serious or life threatening injury to patient. The product is distributed to hospitals and through distributors nationwide.

IMPORTANT NOTICE OF PREVIOUS RELATED RECALLS: 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.

[December 8, 2004 - Press Release - Bio-Med Devices, Inc.]
[December 2, 2004 - Press Release - Unomedical]
[November 30, 2004 - Press Release - Unomedical]