Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: SUNDAY, June 24, 1990 TAG: 9006210232 SECTION: EXTRA PAGE: E2 EDITION: METRO SOURCE: Associated Press DATELINE: WASHINGTON LENGTH: Short
The device, also used to monitor adults who suffer apnea, is manufactured by Electronic Monitors Inc. of Euless, Texas, the FDA said. Those who suffer from apnea temporarily stop breathing during sleep.
The models involved are RE-134B and Mon-A-Therm Respirate, for those older than 4 years old, and Models RE-134C and RE-134D for infants.
"Some models may fail to signal an alarm," the FDA said in issuing a first-class alert, its most serious health warning. The problem, the agency said, is with a defective time delay switch.
FDA said the company was recalling the 1,583 monitors it distributed. Sixty percent went to hospitals and the rest were sent to home health care agencies that rent or distribute them to the public.
"It is not known how many are still being used by consumers," the FDA said.
by CNB