EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Recall Z-1123-2013 · Posted 2013-04-15
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Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFEB
Date Initiated2013-03-22
Date Terminated2013-11-18
Product Quantity273 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.
Firm 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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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