Advanced Sterilization Products Recalls Sterrad 100NX Sterilizers Due to Odor Reports
Advanced Sterilization Products is recalling Sterrad 100NX sterilizers because healthcare workers detected odors, potentially linked to vacuum pump oil breakdown.
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 odor detection without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer, a device used to sterilize heat and moisture-sensitive reusable medical devices. The recall involves 2,106 units total, with 1,224 units distributed in the United States and the remainder distributed worldwide across various regions including EMEA, APAC, Japan, and Canada.
The recall was initiated after some healthcare workers detected odors or smells emanating from the 100NX Sterilizers. The company states that these odors may be related to the normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
Healthcare facilities and users of the Sterrad 100NX Sterilizer should check their equipment against the specific batch codes listed in the official recall notice. Users should contact Advanced Sterilization Products for instructions on how to proceed with the recall and any necessary remediation.
The recalled product
- Product
- Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
Distribution
Distributed nationwide across the United States.
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