Murrysville, Pa.
Respironics announced it had voluntarily recalled more than 5,000 ComfortGel Nasal Masks used to treat sleep apnea. According to a U.S. Food and Drug Administration announcement, the user instructions say the mask contains an exhalation port and does not require a separate exhalation device. However, the product was distributed without the exhalation port, meaning the patient could “experience increased CO2 re-breathing and associated oxygen deficiency. In some cares, suffocation may result,” the announcement said.
The masks were shipped to HME providers and distributors between Sept. 5 and Sept. 15, 2003. The recall was initiated Sept. 29.
Respironics, which reported the problem to the FDA Sept. 26, said it will work closely with the FDA to ensure all masks are returned for thorough inspection, repair or replacements. The company reported that 82 percent of the masks have been returned to Respironics, and less than 3 percent have been reported to be affected. No injuries have been reported to date.
32% of respondents to a HomeCare Web poll said their business outlook for 2004 is very optimistic. Twenty-seven (27) percent said they are somewhat optimistic, and 11 percent said the outlook is unchanged from 2003. Another 19 percent said they are somewhat pessimistic, while 11 percent said they are very pessimistic. The poll was open for three weeks after President Bush signed Medicare reform legislation on Dec. 8.
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