Advanced Sterilization Products Recalls STERRAD 200 Sterilization Systems
Advanced Sterilization Products is recalling STERRAD 200 Sterilization Systems because they may emit unusual odors into the surrounding environment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves an unusual odor without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 1,038 units of the STERRAD 200 Sterilization System, P/N 10201. The product is a general-purpose, low-temperature sterilizer used to inactivate microorganisms on a broad range of medical devices and surgical instruments. The affected units were distributed nationwide in the United States.
The recall was initiated because ASP determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical of normal operating conditions. The source text does not specify the chemical composition of the odor or report any specific health injuries or illnesses associated with the emission.
Users of the affected devices should contact Advanced Sterilization Products for further instructions on how to proceed with the recall. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 1,038
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Codes: 10217 10201-002 10201 10202-001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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