Reported Apr 24, 2013 · Terminated
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect…
Advanced Sterilization Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346
Is this the product you have?
- EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
- Lot codes and dates
- Batch Numbers
893 of 893 codes
504109017750410901275041090131504111030750411200495041120065504112007650411002565041110157504112013350401070295041110264504111026550411102805041100218504110021950411100185041110143504111007950411103295041110212504112015550411002505041110080504111017450411103305041110203504109010350410901105041100103504110010450411001425041090184504109018550411201205041120070504112007350411200805040107087504111015850411001895041100186504111018950410800295041080063504112003450410800285041080060504108006450411001455041100146504110015150411002685041120081504010706550411200875041120116504111011150411101135040107115
- Batch Numbers
- Amount recalled
- 761 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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