Reported Aug 19, 2015 · Terminated

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both…

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?

  • Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
Lot codes and dates

83 of 83 products

Products covered by this recall
Model / numberBarcodesProduct as published
10431501411010400107004210104001070043
1041120390101040010800741041130188 1041130009
1041080082101040010800311041130067
1041130070101040010800921041080188 1041110119 1041120488 1043140137 1041130229 1041090298 1041120061 1041120075 1041120077 1041100288 1041100292 1041080226 1041090350 1041110105 1041110559 1041080078 1041090352 1041120503 1041080185 1041110294 1041120068 1041120025 1041110493 1041120152 1043140124 1041090271 1041080182 1041090303 1041120057 1041120060 1043140054 1041110473 1041090339 1041110057 1041110407 1041120049 1041110515 1041120065 1041120265 1041090280 1041110237 1041090458 1041130155
1041100253101040010800871043140131 1041100060 1043150155 1043150142 1041080179 1041120203 1041110405 1041110443
1043140185101040010700391041090475 1041120139 1041110124
1041110481101040010700441041120476 1041130037 1041090277 1041130150 1043150194 1043150204 1043150196 1041110562 1041120490 1041110431 1041120018 1041110247 1043140085 1043150183 1041120028 1041100047 1041100045 1041080077 1041130440 1041130446 1041130051 1041100243 1041110509 1041100115 1041100294 1041120067 1041100208 1041100213 1041110491 1042080055 1041080061 1041110465 1041110265 1043150172 1043140070 1041100299 1041130129 1041130123 1041090484 1041080174 1041120266
1041100139101040010800691043130262 1041100008 1041100184 1041130175 1043150147 1043150157 1041110520 1041110517 DUP-0033111662 1041110519 1041120497 1043141235 1041110563 1041110038 1041120484 1041120458 1041120272 1043141041 1043130316 1043140059 1041120070 1041120071 1041120003 1041120132 1041120473 1041100024 1041110114 1041090418
104111055610104001080041101040010800371041110164 1041110132 1043140031 1041100081 1041110511 1043150143 1041100306 1041080084
1041080101101040010700581041100118 1041090473 1041110082 1041120326 1041120341
1041120261101040010800431041110003 1041110238 1041070006 1041080186 1041090417 1041120216 1041090361 1041130066 1041130224 1041110552 1041120494 1041100031 1041100315 1041110028 1041100225 1041100227 1041120280 1041100319 1041100324
104315003910104001080020101040010800211041120040
1041130151101040010800851041100077 1041130010 1041110192 1043150195 1043140270
1041100126101040010800631041140074 1041090318 1041100028 1041110434 1041110437
104113022510104001080088101040010800171041110099 DUP10101048613 1041120013 1041120021 1041120449
1041090336101040010800191041100313 1043141346 1041110561 1041120257 1043140325 1043150169 1041120505 1041120576 1041130327 1041130328
1043140045101040010800981041100137 1041100005
1041110083101040010800811041130059 1041100199 1041110060 1041070003 1041110538 1043140308 1041080227 1041100032 1043141261 1043140315 1041110412 1041110422 1041120157 1041100176 1041100127 1041120501 1041110243
1041070008101040010800391010400108004010104001080095 1043141017
1043141016101040010700521041100122 1041110179 1043140076 1041110285 1043141266 1041120296 1041120133 10411201233 1041110404
Amount recalled
1465 units

Where it was sold

  • Nationwide

Why it was recalled

Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

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 May 20, 2016 · Data as of Sep 19, 6:46 PM UTC

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