Reported Dec 31, 2014 · Terminated
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low…
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, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Lot codes and dates
- 1.0104E+13
81 of 81 codes
104107000610411104631041130010104112031710411102881043140062104110004610411103541041120503104111047010411105351043140130104108006310411000171041090452104112049510411302251041090339104112048810431400281041140082104112026610410801941043141011104314026810411001791041100065104111010810411301411041090462104111003310411104281041090416104113017910411303911041130323104314101610410800981041130195104111015010410903921041120216104112004110411100891041120056104113010310411202151041120357104111044910431400311041120463104110012910431302821041110265104110008110431403131041120233104314030810431401311041110015
1.0104E+13 1041120272 1041080227 1043140261 1041100219 1041100261 1041130318 1.0104E+131043130134104113012110410903121041120162104111055710411101791041090488104111052210410700251041090413
1.0104E+13104110012610411101671041130129104111049710411202311041100026104110002410411002911043140188104113019710410801961041090456104314018410410802051041130343104113018610411000571043140084104314009410411200681041090408104313027010410902961041120003104110032410410903841041130150
1.0104E+13 1.0104E+13 1.0104E+131041130151104107001810411202381043140082104112048410410802591041110193104111021310411301751041100299104314101810410700051043130266104111047310411100571043130187
1.0104E+13 1041110144 1041120236 1.0104E+13104111049310411000851041130111104111055210411101331043140284104112048210411100671041120133104108006910410902711041120512104112049610431403021043130280104112017210411201121041120082104111048610411203901041130026104108010010410700171041100119
1.0104E+13 1.0104E+1361 of 61 codes
104113006110411204691041110165104113018410411100771041130221104111006410431403071041140074104111010210431302651043140085104110008310411001281041120228104112034110411000641041130344104111043310431402661041070003104112047310411201321041110491104112004910411205071041110199104108019910411300251041110529104114004110411100211041120302104111004910411002441041110068104108020410410903031041080182104314012310431401791041110305104107002310411304031041100040104112003710411000481043140129104112046010411204891041070015104111026810411203321041080167104112001410411103591041130219104110003510411001761041110250
1.0104E+1364 of 64 codes
104108009110410802191041090443104111009310411100901041120181104112023910411300091041080260104110022810411300501041100137104108008810411001391041130155104113042410411104601041080083104313018910411002451041090300104109033110431400371043140269104314032010411002421041130309104109032210411000881043140318104111051810411204651041110556104113027910411304011041070010104112027810411101001041110073104110001910431302611041100054104314004510411000801041080214104111003210411205051043130285104108008010411302261041110103104110009510411104551041110194104109036010411104141041120486104109042310411100381041110177
1.0104E+131041130210104110003810411300651042080055104108007410411301431041110072104112031910411100391043140323104314018510411001991041080059104112051110411300991043130191104111026310431302621043130246104211000310431403111041070147104111008610411200121041100140104110014110411104191041140038104109029410411202301041120217104113019610411100631041100210104107004910411201281041100218104112001010411303241041120218
1.0104E+131043140300104211000510421201411041090403104108020710431400361041130105104314012810411302241041120028104314008110410801741041120387104113041510411204831041100071104314027610411204541041080076104110031210411205081041090279104108017710411102141041080057104110005310411100361041100127104111009910410801681041110171104112044710411100841043140125104113026010431402701041120296104111000410410801981043140092104108015910410903501043141013104111011810410903471041090485104112004710411101281041080082104113014610411201061041130060104110032510411002881043140325104111011210411104251041130193
1.0104E+13 1041110218 1041090268 1041090280 1041110124 1041110044 1041100028 1041110434 1.0104E+131041120485104313027310411205791041120289104113031510411100751041120052104314026710410700481041130229
1.0104E+1310411104431041110087104314028610431301051041110492104314018010431400731041110163
1.0104E+13104110011810411105021041130223104108008610411101821041080079104111048110411105621041120340104108019310410903611041120573
1.0104E+1310410903961041080228104109027210411104831042070037104111013210411203161041090407104113039510411102151041100184104111049910411002291041080084104110018110411102351041080090
1.0104E+13131 of 131 codes
104111008210410904871041110272104109035910411001731041110285104108018910410800611041110465104314007810431401621041130170104111043110431302751041100063104113017210411300531041110037104111028310411104091041110147104112006910411102061041130122104109045810411301251041120020104113034210411102561041100166104112044510411203671041120073104108023010411101921041080089104111006210410903401041130166104109048910411101061041100117104112048010411001161041080077104109046010411201741041100308104107001610411101201041110506104113026610410902911041090484104109039510411200461041070004104111051310410700081041110441
1.0104E+1310411100701041100253104109027810411203891041120111104111000210411301771041090366
104109033610411204991041110524104108009910411104231041090287104113016110431301901041100178104111052510431401341041130064104110014710411201031041110515104314009110431401351041110141104113013510410801951043130188
- Amount recalled
- 19,978 units total (9,792 units in US)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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