Reported Aug 5, 2020 · Terminated
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage:…
Steris Corporation
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: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity
- and ECO) - Product UsageSTERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments
- Lot codes and dates
- Serial numbers01 0817 87702 02
79 of 79 codes
111675398011116753980211167539803011675398041216753980611167440102011777359031116753981101177735902011777359010117773590601177735904011777359051216753980801167539810021779750011216753980901177736803011777368040117773680501177736806011777368080217797500201177736807021779567010217795670202177956703021779567040217795670503177956706021779567100317795670703177956708021779567110317795670903177956901031779569020217795690703177956903031779569040317795690503177956906031779571110417795710504177957106041779571070417795710804177957109041779571100517820370205178203703051782037040517820370505178203701051782037060517820370705178203708051782037090517820371006178204001
01 0917 88031 02 0917 88031 03 0917 88031 04 0917 88031 05 0817 87702 04 0817 87702 030617846090806178460909061784609100617846091106178460912061784609130617846091406178460915051782037130817847830106178204011081784783020817847830306178204012081784783040817847830508178478306081784783070817847830806178460917081784783090817847831008178478311081784783120817847831408178478315091788031
01 08178478317 1017 88034 02 0917 87702 06 09178478318 1017 88034 03 1017 88034 05 1017 88034 06 1017 88034 07 10178427712 0917 87702 07 1017 88034 08 1017 88034 09 1017 88034 10 1017 88034 11 1017 88034 12 1017 88034 13 1017 88034 14 08178478313 1017 88034 15 1217 88033 01 1217 88033 02 1217 88033 03 1217 88033 04 1217 88033 05 1217 88033 06 01188948301 01188948302 10178427713 01188948303 0917 87702 08071784609180917842770109178427702091784277030917842770409178427705061782040050917880310609178803107091788031080917880310909178803110091784277060917842770709178427708091784277090917842771009178803111101788034
07 1117 88034 16 1117 88034 17 1117 88034 18 1217 88033 08 1217 88033 09 1217 88033 11 1217 88033 12 1217 88033 13 1217 88033 14 0917 87702 10011889483040118894830501188948306011889483070118894830801188948310121788033
02 1017 88035 03 1017 88035 04 01189087707 1017 88035 05091788031120118908770112178803316121788033170118908770201189087703011890877040218908772402189087723011890877050118908770602189087721101788035
06 01189087714 01189087715 01189087716 1017 88036 01011890877080118908770901189087710011890877110118908771201189087713101788035
0201189087718011890877190118908772003189220501031892205020118908771703189220503031892205040318922051603189220517101788036
03031892205110318922051203189220513031892205140318922051504189322801041893228020418932280303189220505031892205200318922051903189322821031892205060318922050803189322822031892205090318922051004189322804041893228050418932280604189322807041893228080418932280903189322825041893228100318932282404189322811031893228230418932281204189322813041893228150418932281603189220521041893228260418932281704189322819101788036
050518943792104189322820051894379230518943790105189437902051894379030518943790605189437907051894379080518943790906189437924051894379040518943790505189437910101788036
04112 of 112 codes
051894379110518943791206189437925051894379130518943791405189437915051894379160518943791705189437918051894379200718971660107189716602071897166080618955870106189558706061895587030718971661006189558704071897166090618955870706189558705071896865040718968650207189686503071896865050718971660308189716612071897166040718971660506189558709081898734060718971660607189716607081896865060818968650706189558710081896865080818968650908189686510071896865110818987340808189843301081898433020818984331308189843314081898433030718968651208189843304091898433050918984331609189843306091898433070518943792208189686611091898433080918984330909189843311091898433100817847831609189843312
091018985560110189898805121898556131218985561412189855616111898555221218985561712189855618121898556191018985560210189855603011998703
894 of 894 codes
121898555231018985560412189855525011998703111218985552406189558708011998703130119987031408189873401011998703100119987031201199870315011998703160119987031701199870319011999444030119996120301199870318011998703200119987032101199855622121898556201218985562101199870322011998556240119994440101199961206011998703230119989910501199899106011999612010119996120201199961204011999612050119985562508189873402111898703240119987030111189870325011998991070119989910801199899109011998991100119985562301199870302021999624010219996240202199962403021999624040219989911402199899116021998991170219989911802199899119021998991120219989911302199962405021999624060219989911501199870303
- Serial numbers
- Amount recalled
- 1283
Where it was sold
- Nationwide
Why it was recalled
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
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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