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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Recall Number Z-1150-2013
Classification Class II
Code Info Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 5041100214 5041100265 5041110186 5041110187 5041100067 5041100071 5041100079 5041110075 5041110078 5041120111 5041100136 5041100164 5041100043 5041100046 5041100047 5041110191 5041100262 5041110155 5041110154 5041110327 5041090128 5041110185 5041120060 5041120108 5041110316 5041110231 5041110246 5041090146 5041110291 5041120203 5041090061 5041090063 5041100068 5041100076 5041100222 5041090205 5041090097 5041090141 5041110182 5041090145 5041090129 5041100257 5041120149 5041120152 5041110127 5041130007 5041130008 5041120137 5041110176 5041110188 5041110183 5041100126 5041100127 5041100156 5041070042 5041080077 5041090108 5041100197 5041110120 5041100162 5041090194 5041110131 5041110142 5041110147 5041120094 5041080071 5041080062 5041090175 5041110172 5041110173 5041120071 5041090182 5041100036 5040107105 5041100248 5041100251 5041120150 5041090090 5041090092 5041100077 5041100081 5041100089 5041100259 5041100167 5041100020 5041100025 5041100220 5041120036 5041100205 5041100211 5041110213 5041120179 5041120185 5041110283 5041110315 5041100233 5041100107 5041100108 5041100116 5041100117 5041110228 5041110247 5041110257 5041110333 5041110238 5041110229 5041100022 5041100017 5041110108 5041100241 5041100232 5041100242 5041110322 5041090015 5041090170 5041100041 5041100010 5041100011 5041120099 5041100038 5041100202 5041110115 5041090112 5041100264 5041090086 5041120124 5041100124 5041100129 5041100266 5041100267 5041120143 5041120202 5041090137 5041090164 5041100102 5041100132 5041120129 5041120132 5041120096 5041090031 5041090169 5041090057 5041090060 5041090101 5041100004 5041090093 5041090099 5041110073 5041120190 5041110239 5041090180 5041120209 5041110161 5041110162 5041090134 5041120172 5041100062 5041110092 5041120023 5041120097 5041110274 5041120088 5041090104 5041090113 5041120174 5041100019 5041110088 5041110106 5041110318 5041100115 5041090087 5041110039 5041100015 5041090161 5041100225 5041110332 5041100002 5041100003 5041120146 5041120114 5041100223 5041110116 5041120199 5041120091 5041110326 5041080070 5040107114 5041080076 5041090091 5041120004 5041100096 5041110263 5041110262 5041110242 5041110255 5041110259 5041120068 5041110205 5041120035 5041080058 5041110219 5041100182 5041090198 5041120213 5041120101 5041100183 5041100074 5041110016 5041110254 5041080078 5041090139 5041120112 5041100048 5041120208 5041090144 5041090140 5041090193 5041100007 5041100128 5041100138 5041100188 5041110284 5041120107 5041120131 5041120169 5041120178 5041120184 5041100180 5041120206 5041110006 5041110012 5041130010 5041130011 5041100080 5041110098 5041110100 5041120103 5041120141 5041080057 5041080065 5041080066 5041080072 5041090098 5041090100 5041090221 5041100024 5041100034 5041100092 5041100023 5041100028 5041100240 5041100243 5041100249 5041100244 5041100173 5041100245 5041100069 5041110122 5041110124 5041110125 5041110126 5041110159 5041110160 5041110256 5041100082 5041100083 5041120047 5041120048 5041120054 5041120168 5041120176 5041100210 5041110220 5041120069 5041110215 5041110221 5041110223 5041110224 5041110323 5041100012 5041100178 5041110041 5041110007 5041090106 5041090022 5041110268 5041110200 5041110023 5041130005 5041100086 5041110135 5040107109 5040107111 5040107121 5041110040 5041110026 5041110090 5041110093 5041120002 5041120006 5041110245 5041110236 5041110237 5041090174 5041090178 5041120192 5041090053 5041120110 5041120119 5041100153 5041090028 5041120194 5041120200 5041120171 5041110109 5041080027 5041090187 5041090216 5041120167 5041120063 5041120072 5041120074 5041110225 5041110270 5041120079 5041120064 5041100246 5041100247 5041110144 5041110145 5041120197 5041110015 5041110017 5041100130 5041110110 5041090138 5041100098 5041090206 5041100125 5041120005 5041100261 5041070048 5041090204 5041090210 5041090214 5041090215 5041120015 5041110038 5041110037 5041100013 5041100014 5041100037 5041100039 5041120066 5041090056 5041090058 5041120092 5041090160 5041110022 5041110028 5041110029 5041110107 5041110190 5041110324 5041100228 5041110123 5041090136 5041120003 5041110211 5041110233 5041120195 5041100254 5041080024 5041100032 5041100198 5041100200 5041100203 5041100204 5041100207 5041110199 5041120198 5041120022 5041120018 5041120210 5041120211 5041090135 5041100258 5041110077 5041110222 5041100088 5041090105 5041100090 5041070035 5041070041 5041100016 5041110021 5041090191 5041090219 5041120142 5041110192 5041090094 5041100031 5041110086 5041120040 5041100042 5041100045 5041100131 5041110197 5041110198 5041110031 5041120053 5041110070 5041120041 5041110207 5041120026 5041120027 5041090102 5041090118 5041090120 5041120038 5041120044 5041120045 5041120013 5041100227 5041090197 5041110085 5041120117 5041110230 5041110235 5041110240 5041120139 5041120212 5041100231 5041110178 5041110179 5041100073 5041110175 5041120130 5041110101 5041120126 5041090222 5041090176 5041090220 5041110133 5041120151 5041100064 5041110249 5041100006 5041100009 5041100100 5041100095 5041100094 5041100121 5041120177 5041120183 5041110248 5041110258 5041120029 5041120030 5041120031 5041100018 5041120147 5041110261 5041110267 5041110102 5041110074 5041110279 5041110320 5041110163 5041090109 5041090121 5041110081 5041110084 5041100179 5041100185 5041100187 5041110117 5041110319 5041110206 5041090188 5041090190 5041110141 5041110146 5041100226 5041110009 5041120046 5041100230 5041100229 5041110218 5041100253 5041100021 5041090107 5041110290 5041120127 5041100049 5041100050 5041100051 5041100059 5041120061 5041120215 5041120145 5041100168 5041080012 5041080019 5041090114 5041090119 5041110013 5041110132 5041110195 5041110196 5041120037 5041100060 5041100061 5041110011 5041110020 5041110025 5041090130 5041110091 5041110082 5041090018 5041120014 5041120021 5041120025 5041120028 5041100135 5041100044 5041120182 5041100070 5041100075 5041110269 5041110272 5041110275 5041100255 5041090181 5041110024 5041120143 5041120144 5041120175 5041120181 5041110209 5041110216 5040107101 5040107108 5041120085 5041120102 5041100152 5041100155 5041090089 5041090095 5041090017 5041090019 5041090020 5041090021 5041110250 5041110266 5041110171 5041110232 5041100106 5041100221 5041110306 5041090209 5041100030 5041120104 5041120043 5041090192 5041120016 5041110134 5041100161 5041120011 5041090123 5041090033 5041090207 5041100026 5041120075 5040107106 5041080073 5041120214 5041110164 5041090189 5041120125 5041080068 5041120113 5041120078 5041110153 5041110099 5041110104 5041120156 5041110076 5041100137 5041100139 5041120050 5041100093 5041100084 5041100087 5041100263 5041110277 5041110276 5041090165 5041120153 5041100176 5041110184 5041120173 5041120201 5041100029 5041100215 5041090071 5041100177 5041120100 5041120106 5041070043 5041090154 5041110208 5041120067 5041110278 5041120051 5041120057 5041100239 5041100260 5041090157 5041090159 5041110002 5041120007 5041110260 5041100005 5041100122 5041100097 5041100118 5041120166 5041100099 5041100101 5041120019 5041120020 5041100196 5041100206 5041120170 5040107104 5040107112 5041100078 5041110114 5041120055 5041090152 5041100224 5041120180 5041120039 5041120024 5041120136 5041120140 5041090064 5041090068 5041110241 5041120058 5041100150 5041100133 5041100134 5041100154 5041100208 5041100209 5041100201 5041100148 5041090110 5041090080 5041090208 5041090211 5041110321 5041120109 5041090115 5041090218 5041120138 5041120193 5041120077 5041110227 5041110273 5041110281 5041110317 5041110128 5041090156 5041110150 5041110156 5041110151 5041110152 5041110148 5041070038 5041080020 5041070039 5041120086 5041120089 5041120090 5041080061 5041090024 5041120009 5041120010 5041120012 5041120042 5041090124 5041090125 5041090126 5041120148 5041090217 5041100181 5041120093 5041090153 5041100195 5041100199 5041110149 5041120084 5041110087 5041120052 5041120056 5041120059 5041120216 5041130004 5041130006 5041110136 5041110137 5041110003 5041080013 5041080059 5041080069 5040107073 5041090158 5041090023 5041110083 5041120123 5041080014 5041110217 5041120095 5041120098 5041090116 5041090117 5041080079 5041110251 5041090143 5041110004 5041110008 5041110252 5041110253 5041090155 5041100149 5041100163 5041100169 5041100170 5041100172 5041090066 5041110071 5041110180 5041110234 5041110019 5041110032 5041110033 5041110034 5041110035 5041120191 5041120196 5041120121 5041120122 5041120062 5041120105 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041100091 5041110005 5041110014 5041110036 5041110210 5041100174 5041100175 5041110194 5041110214 5041110226 5041090151 5041080074 5041080015 5041080017 5041090096 5041090103 5041100085 5041100171 5041100184 5041100159 5041100065 5041100066 5041100252 5041080067 5041120017 5041100123 5041100193 5041090183 5041090186 5041110325 5041090070 5041100033 5041090062 5041090132 5041090212 5041090213 5041100072 5041120008 5041120115 5041090122 5041090133 5041090142 5041100027 5041120118 5041110305
Product Distributed Qty 761 units
Reason For Recall Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.

Event Detail

Event Id 64781
Product Type Devices
Status Ongoing
Recalling Firm Advanced Sterilization Products
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution
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