Recall Z-1150-2013
Advanced Sterilization Products · initiated March 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Codes / lots: 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…
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1150-2013
- Initiated
- March 28, 2013
- Posted by FDA
- April 18, 2013
- Terminated
- August 22, 2013
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Quantity
- 761 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Advanced Sterilization Products, Irvine, CA