STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Check against the official notice below — it lists the full affected range.
Advanced Sterilization Products is recalling 7,694 units of the STERRAD NX Sterilization System (Product Code 10033 and 10033-002) distributed worldwide, including 5,935 units in the United States. The recall affects units with specific serial numbers that have been identified as potentially affected by a defect where the system door interlock can disengage for approximately 20 seconds during system reboot following an external power outage, though this is described as occurring only in rare circumstances.
The recall notice does not specify a remedy or any corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
Reason for recall: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Fede Quantity: 7,694 units total (5,935 units in US) Lot/code info: Serial No 33100270 33110267 10033070599 33110166 33102348 10033070293 10033070296 10033070115 10033060166 33111764 33120476 10033050564 33130497 10033070381 10033070382 10033060659 33101036 33110266 33110308 33101084 33101087 33120355 33110445 33120379 1033160123 33101078 10033060377 33090564 33081028 33120585 33090532 10033060637 33130516 33110446 33110894 33111832 33111336 33111363 33111573 33111580 33110148 33101330 33120120 10033060898 33100023 33090562 33101545 33101573 33090528 10033070039 10033060706 33100367 10033050651 10033050652 10033050653 10033060178 10033070271 33110891 33120063 33111632 33081444 33081449 33111445 33101574 33120131 33130325 10033080299 33101333 33101352 1033142129 33130407 33111725 10033060230 33111710 33120162 33120165 33110448 33110454 10033080184 10033080185 10033080035 33101110 33101113 33101121 10033070022 10033070023 10033070026 10033070143 10033070144 10033070168 33110864 33110870 33101124 33101130 33090338 10033060582 10033070514 10033060285 33120537 10033070064 1033150476 33110057 33090500 33090510 33090515 33090524 33102301 33102359 10033070618 10033060837 10033060836 10033050216 33111413 33100063 33120518 33130559 1033142050 1033150314 33090190 33090192 33100316 33111679 10033070772 33110592 33100205 33100233 10033060811 33090428 33090397 33090404 10033050496 10033060620 10033060933 10033070075 33120294 10033080224 33110745 10033060510 33111674 10033050452 33102368 33120617 10033070889 10033070894 1033142096 33111551 33111579 10033080
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.