Reported Sep 18, 2013 · Terminated

STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose…

Advanced Sterilization Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346

Is this the product you have?

  • STERRAD 100NX Cassettes
  • Product Code10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices
Lot codes and dates
  • Lot/Batch Numbers10104001070010*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*

    1,549 of 1,549 codes

    • 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
    10104001070020*JABIL 10104001070018*JABIL 10104001070019*JABIL 10104001070021*JABIL 10104001070023*JABIL 10104001070022*JABIL 10104001070025*JABIL 10104001070026*JABIL 10104001070027*JABIL 10104001070032*JABIL 10104001070031*JABIL 10104001070035*JABIL 10104001070036* 10104001080018*JABIL 10104001080032* 10104001080024*JABIL 10104001080089*JABIL 10104001080091*JABIL 10104001080096*JABIL 10104001080064*JABIL 10104001080071*JABIL 10104001080078*JABIL 10104001080079*JABIL 10104001080079*FG 10104001070065*JABIL 10104001070062*JABIL 10104001070060*JABIL 1041070009*JABIL 1041070014*JABIL 1041070013*JABIL 1041080062* 1041070020* 1041070024* 1041070021* 1041080065* 1041080092* 1041070052* 1041080161* 1041080171* 1041080094* 1041080162* 1041080170* 1041080085* 1041070050* 1041080166* 1041080187* 1041080181* 1041080192* 1041080183*
Amount recalled
1,923 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 27, 2013 · Data as of Sep 19, 4:46 PM UTC

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