FDAFDA · Alimentos y medicamentos·N.º oficial Z-1197-2017
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Publicado el 22 de febrero de 2017 · Inicio del retiro: 9 de enero de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Sterilization Products
- Distribuidor
- 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 Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
- Lote
- 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 10033080232 33120395 33111461 33111463 33111473 33111478 33111479 33111483 10033060502 33120721 33100483 33111084 1033150315 10033071045 33111277 33111280 33100208 33100209 33120481 33120482 33140044 33101457 33101458 10033060150 10033060275 10033080324 10033080325 33100422 33100460 33100471 10033070493 33100418 33081236 33101474 33101478 33101406 33110829 33110852 10033070673 10033070674 33090113 10033050252 33111028 33111040 33100448 10033080157 33110052 33100227 33110047 10033060702 10033060703 33111521 33120221 33102328 33100124 33101105 1033150350 33120121 33111499 33110836 33100400 33120217 33102213 33102216 33111974 10033080079 10033080084 33111604 33111517 10033060983 10033070664 10033070665 10033060665 33111258 33111264 33100330 33100332 33100534 10033070651 33111566 33120347 10033070748 10033050640 33110936 33111398 33111402 33110034 1033142064 33110327 10033070448 10033080313 33111393 33111405 33090360 33100078 33100084 33111382 10033060121 33081426 10033070368 33090001 33111874 33090438 33090460 33090463 33100336 33100372 33110196 33110771 33110743 33111523 33111854 10033060315 33081023 33081024 33101079 33101080 10033050647 10033080068 33120717 10033080023 33111200 33111457 33101000 33120073 33100518 33100522 33102330 33140025 33100053 33111454 33110045 33110050 33110054 33111446 33100037 33111895 10033070436 33120089 1033142060 33102134 33102135 33111356 10033080076 10033070751 33100378 10033070571 10033070108 33111671 33111676 33101562 33111105 33110197 10033070428 33102292 33102308 33102314 33102320 33102326 33101526 33110587 33120318 33102321 33110132 10033050184 10033050580 33100604 33100607 33111178 1033150345 33120102 33120104 33102285 10033050271 33100544 33110100 33110117 33110123 33110124 33110141 33111713 33120672 10033080348 10033070341 10033060913 33090334 33100167 10033070380 33111920 33110101 10033070182 33090277 33110300 33110301 33102204 10033080247 33110483 33110799 33110409 33110410 33130529 10033050238 33110150 33120729 10033060940 33090495 10033060558 10033070121 10033070122 33101650 33101658 33102115 33110820 33090177 33090212 33101138 10033050672 33120154 10033070394 3
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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