FDAMay 22, 2017device
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog Number/Description: 007168 P...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
What to do
FDA enforcement status: Terminated
Brands named
natus medicalnatus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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