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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 Device 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
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
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Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
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
Nonconforming Material/Component
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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