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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 & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Recall Number Z-1123-2013
Classification Class II
Code Info Serial Numbers: 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107 5041120100 5041120106 5041120087 5041120116 5041120114 5041120113 5041120112 5041120111 5041120081 5041120067 5041120109 5041120118 5041120123 5041120110 5041120119 5041120125 5041120126 5041120117 5041120129 5041120132 5041120115 5041120127 5041120131 5041120121 5041120122 5041120130 5041120124 5041120133 5041120139 5041120136 5041120140 5041120137 5041120138 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041120148 5041120149 5041120152 5041120153 5041120154 5041120155 5041120151 5041120150 5041120120 5041120169 5041120168 5041120176 5041120172 5041120141 5041120156 5041120142 5041120147 5041120146 5041120171 5041120145 5041120175 5041120181 5041120170 5041120173 5041120177 5041120183 5041120180 5041120182 5041120197 5041120179 5041120178 5041120190 5041120193 5041120184 5041120191 5041120196 5041120199 5041120192 5041120201 5041120203 5041120200 5041120194 5041120174 5041120198 5041120195 5041120185 5041120213 5041120206 5041120214 5041120208 5041120209
Product Distributed Qty 273 units
Reason For Recall Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.

Event Detail

Event Id 64700
Product Type Devices
Status Ongoing
Recalling Firm Advanced Sterilization Products
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
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