FDAFDA · Food and drugs·Recall number Z-2174-2013
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.
Published September 18, 2013 · Recall initiated: July 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- 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.
- Lot
- 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*JABIL 10104001070042*JABIL 10104001070044*JABIL 10104001070050*JABIL 10104001070053*JABIL 10104001070054*JABIL 10104001070052*JABIL 10104001070051*JABIL 10104001070055*JABIL 10104001070059*JABIL 10104001070058*JABIL 10104001070057*JABIL 10104001070056*JABIL 10104001070061*JABIL 10104001070064*JABIL 10104001070063*JABIL 1041070007*JABIL 1041070015*JABIL 1041070005*JABIL 1041070003*JABIL 1041070006*JABIL 1041070016*JABIL 1041070008*JABIL 1041070017*JABIL 1041070010*JABIL 1041070004*JABIL 1041070011*JABI 1041070018*JABIL 1041070019* 1041080063* 1041080055* 1041080059* 1041080056* 1041080057* 1041070023* 1041070022* 1041080073* 1041080072* 1041080071* 1041080069* 1041080066* 1041080074* 1041080077* 1041080076* 1041080082* 1041080061* 1041080078* 1041080079* 1041080081* 1041080087* 1041080080* 1041080095* 1041080093* 1041080090* 1041080088* 1041080089* 1041080097* 1041080091* 1041080098* 1041080099* 1041080100* 1041080101* 1041080096* 1041080104* 1041080159* 1041080103* 1041080102* 1041080160* 1041080172* 1041080167* 1041080168* 1041080169* 1041070049* 1041080174* 1041070048* 1041080083* 1041080086* 1041080164* 1041080163* 1041080182* 1041080180* 1041080084* 1041080184* 1041080186* 1041080189* 1041080185* 1041080177* 1041080179* 1041080178* 1041080191* 1041080193* 1041080199* 1041080197* 1041080198* 1041080188* 1041080215 1041080194 1041080214 1041080260 1041080206 1041080205 1041080212 1041080204 1041080196 1041080203 1041080259 1041080202 1041080082 1041090269 1041070047 1041080216 1041080220 1041090264 1041070155 1041090263 1041090265 1041070154 1041070156 1041090268 1041090270 1041090275 1041090276 1041090279 1041090277 1041090273 1041080219 1041080207 1041090266 1041090271 1041090343 1041090340 1041090331 1041090300 1041090333 1041090338 1041090322 1041070149 1041070025 1041070147 1041080230 1041090352 1041090350 1041080226 1041080225 1041090272 1041090278 1041090280 1041090267 1041080218 1041090287 1041080230 1041080228 1041080221 1041090291 1041090288 1041090292 1041090283 1041090289 1041090284 1041090355 1041090354 1041088875 1041088994 1041089114 1041089234 1041089354 1041089473 1041089593 1041089713 1041089833 1041089952 1041090072 1041090192 1041090312 1041090431 1041090551 1041090671 104
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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