SmartMonitor 2 Infant Apnea Monitor hits FDA Class I recall list.
West Palm Beach, FL(JusticeNewsFlash.com)–The U.S. Food and Drug Administration (FDA) http://www.fda.gov updated an April 23, 2009, SmartMonitor 2 Infant Apnea Monitor, potential defective product risk to the federal Class I recall list. A Class I recall is the highest and most serious recall a defective product can be labeled in the United States, which means the product has a reasonable probability of causing serious injury or death. On Monday, May 18, 2009, the FDA and Respironics Inc., a medical device company who makes products for health care providers and consumers, recalled SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003.
The medical product, used by health care providers and parents for the continuous monitoring of an infants breathing and heart rate while in the hospital or at home, was recalled because it can fail to alarm when a baby stops breathing or their heart slows to dangerously low levels. Respironics, a Pennsylvania based medical device manufacturer, states the product was made from January 16, 2008, through November 13, 2008, and distributed from January 17, 2008, through December 31, 2008. The defective medical device maker and regulators with the FDA alert all consumers, hospitals, and all health care providers to stop using this product immediately, return all units to the company, and report any problems to their doctor and the FDA. If you require emergent health care, call your local emergency medical services (EMS) personnel provider or go to the nearest emergency room. Go to www.fda.gov/MedWatch/report.htm to report any adverse reactions and use the FDA’s MedWatch Adverse Event Reporting program. Customers are also urged to contact Respironics directly at 1-888-345-4630.
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