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Unomedical Manual Pulmonary Resuscitator - Recall
Audience: Pulmonary healthcare professionals, emergency response personnel
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.
Read the complete MedWatch 2009 Safety summary, including links to the firm's press release and product photos, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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