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U.S. Department of Health and Human Services

Safety

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Unomedical Manual Pulmonary Resuscitator - Recall

Audience: Pulmonary healthcare professionals, emergency response personnel 

[UPDATED 11/03/2009] Recall classified as Class I.

[Posted 10/07/2009] Unomedical and FDA notified healthcare professionals about the recall of the single-patient use Manual Pulmonary Resuscitator because of a malfunction which may impair the ability of the device to generate the positive pressure necessary to function properly and could potentially cause serious adverse health consequences or death. The recalled resuscitators were manufactured from July 2002 – March 2008 and the company set up a web page, http://www.unomedical.com/?pageid=H3160 with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

[11/03/2009 - Recall Notice - FDA]
[10/06/2009 - Press Release - Unomedical Inc.]
[10/06/2009 - Product Photo - Unomedical Inc.]