STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Check against the official notice below — it lists the full affected range.
Advanced Sterilization Products is recalling 1,923 units of STERRAD 100NX Cassettes (product code 10144) because the company does not have adequate data to confirm that the packaging's leak indicator works effectively throughout the cassette's entire 15-month shelf life. The STERRAD 100NX is a low-temperature sterilization system used to sterilize heat and moisture-sensitive medical devices. The affected cassettes were distributed worldwide, including throughout the United States and to numerous countries across Europe, Asia, the Middle East, Africa, and the Americas.
The specific lot and batch numbers affected by this recall are listed in the official recall documentation. The source document does not specify what actions consumers or healthcare facilities should take regarding recalled units.
Written by software from the official notice below. Not reviewed by a lawyer.
The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.
Reason for recall: The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life. Distribution: Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela. Quantity: 1,923 units Lot/code info: Lot/Batch Numbers: 10104001070010*JABIL 10104001070012*JABIL 10104001070037*JABIL 10104001070038*JABIL 10104001070039*JABIL 10104001070040*JABIL 10104001070041*JABIL 10104001080027*JABIL 10104001080020*JABIL 10104001080025*JABIL 10104001080026*JABIL 10104001080028*JABIL 10104001080029*JABIL 10104001080030*JABIL 10104001080031*JABIL 10104001080033*JABIL 10104001080035*JABIL 10104001080034*JABIL 10104001080036*JABIL 10104001080037*JABIL 10104001080095*JABIL 10104001080087*JABIL 10104001080092*JABIL 10104001080090*JABIL 10104001080017*JABIL 10104001080019*JABIL 10104001080088*JABIL 10104001080039*JABIL 10104001080038*JABIL 10104001080041*JABIL 10104001080042*JABIL 10104001080069* 10104001080043*JABIL 10104001080046*JABIL 10104001080085* 10104001080086* 10104001080059* 10104001080060*JABIL 10104001080061* 10104001080063*JABIL 10104001080065*JABIL 10104001080062*JABIL 10104001080048*JABIL 10104001080049*JABIL 10104001080047*JABIL 10104001080050*JABIL 10104001080051*JABIL 10104001080053*JABIL 10104001080052*JABIL 10104001080054*JABIL 10104001080055*JABIL 10104001080056*JABIL 10104001080057*JABIL 10104001080068*JABIL 10104001080058*JABIL 10104001080070*JABIL 10104001080072*JABIL 10104001080073*JABIL 10104001080074*JABIL 10104001080075*JABIL 10104001080076*JABIL 10104001080077*JABIL 10104001080080*JABIL 10104001080081*JABIL 10104001080082*JABIL 10104001080097*JABIL 10104001080084*JABIL 10104001080099*JABIL 10104001080100*JABIL 10104001080098*JABIL 10104001070041*JABIL 10104001070043*
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.