Advanced Sterilization Products Recalls STERRAD 200 Sterilizers for Odor Emission
Advanced Sterilization Products is recalling STERRAD 200 Sterilizers because they may emit unusual odors into the surrounding environment.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The hazard is an unusual odor emission, which is a cosmetic or minor operational defect without reported injuries, illnesses, or structural failures, fitting the criteria for a Low severity recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System, including Single Door (Part Number: 10201) and Double Door (Part Number: 10202) models. The recall involves 1,305 units distributed worldwide, including 654 units in the United States and 651 units outside the US.
The recall was initiated because the devices may emit an odor or smell into the surrounding environment that is not typical of normal operating conditions. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat- and moisture-sensitive reusable medical devices.
No specific instructions for consumers are provided in the source text. Users of these devices should monitor for unusual odors during operation.
The recalled product
- Product
- STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
- Hazard
Distribution
Distributed nationwide across the United States.
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