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U.S. Department of Health and Human Services

Class 2 Device Recall EVOTECH Endoscope Cleaner & Reprocessor System

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 Class 2 Recall
EVOTECH Endoscope Cleaner & Reprocessor System
see related information
Date Posted April 15, 2013
Recall Status1 Terminated on November 18, 2013
Recall Number Z-1123-2013
Recall Event ID 64700
Premarket Notification
510(K) Number
K082392 
Product Classification Accessories, Cleaning, For Endoscope - Product Code FEB
Product EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Code Information Serial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 5041110085 5041110092 5041110091 5041110077 5041110079 5041110086 5041110081 5041110084 5041110080 5041110087 5041110105 5041110099 5041110104 5041110101 5041110088 5041110106 5041110090 5041110093 5041110110 5041110108 5041110115 5041110112 5041110116 5041110114 5041110107 5041110074 5041110102 5041110111 5041110113 5041110098 5041110100 5041110071 5041110073 5041110117 5041110123 5041110122 5041110124 5041110125 5041110126 5041110109 5041110127 5041110120 5041110129 5041110130 5041110134 5041110128 5041110135 5041110143 5041110136 5041110137 5041110121 5041110140 5041110132 5041110131 5041110144 5041110145 5041110141 5041110146 5041110133 5041110142 5041110147 5041110148 5041110150 5041110151 5041110152 5041110156 5041110149 5041110157 5041110153 5041110154 5041110155 5041110158 5041110159 5041110160 5041110161 5041110162 5041110171 5041110164 5041110172 5041110173 5041110175 5041110163 5041110176 5041110177 5041110179 5041110178 5041110180 5041110182 5041110185 5041110184 5041110183 5041110186 5041110187 5041110189 5041110190 5041110192 5041110174 5041110191 5041110194 5041110195 5041110196 5041110188 5041110199 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
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An Urgent Medical Device Field Correction letter, dated 3/22/13, was sent to customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR) HIPOT Testing. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed on what to do if electrical shock occurs. Customers are instructed that they will be contacted in the next 2 weeks on behalf of ASP to schedule HIPOT testing. Customers with questions are instructed to contact Stericycle at (888) 965-5816. Customers are instructed to report complaints or suspected problems with their EVOTECH ECR system by contacting ASP Professional Services directly at (888) 783-7723 and select option #2.
Quantity in Commerce 273 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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