Events

Recall of Device Recall EVOTECH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1150-2013
  • Event Initiated Date
    2013-03-28
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117051
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, cleaning, for endoscope - Product Code FEB
  • Reason
    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.
  • Action
    An Urgent Medical Device Field Correction letter dated 3/28/13 was sent to all customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR). The letter informed the customers of the problems identified and the actions to be taken. Customers are informed that the failure can potentially cause the following outcomes for the cycles listed below: 1. In the Full Reprocessing Cycle (Cleaning and HLD): there is a potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes. 2. In the HLD-Only Cycle: there is potential for an adequate amount of high-level disinfectant solution to be sent through some endoscope channels. If customers observe smoke, then they are instructed to: a. Power OFF the device. b. Report your incident to ASP Professional Services at (888) 783-7723 and select option #2. c. Do not use the device until it has been serviced by ASP. Customers are instructed to return attached buyer return card acknowledging their receipt of this communication. Customers are instructed to contact Stericycle at (866) 761-9566 for any questions related to the field correction.

Device

Device Recall EVOTECH
  • Model / Serial
    Batch 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0254 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 Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • 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.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA