Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems
Advanced Sterilization Products is recalling STERRAD NX Sterilization Systems because the door interlock may disengage for 20 seconds after a power outage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a safety interlock failure on a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 7,694 units of the STERRAD NX Sterilization System (Product Codes 10033, 10033-002) worldwide, including 5,935 units in the United States. The recall affects units distributed to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
The recall was initiated because ASP identified a rare sequence of events where the system door interlock can become disengaged for a 20-second duration during a system reboot following an external power outage. This defect could potentially allow the door to be opened while the system is in a state where it should be secured.
Healthcare facilities and users of these sterilization systems should check their equipment serial numbers against the list provided by the FDA or the manufacturer. If a unit is affected, users should contact Advanced Sterilization Products for instructions on how to proceed with the recall and corrective actions.
The recalled product
- Product
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
- Manufacturer
- Advanced Sterilization Products
- Hazard
Distribution
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