Reported Apr 24, 2013 · Terminated
EVOTECH Endoscope Cleaner & 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 & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
- Lot codes and dates
- Serial Numbers
273 of 273 codes
504111002650411100705041110041504111008250411100835041110076504111007550411100785041110085504111009250411100915041110077504111007950411100865041110081504111008450411100805041110087504111010550411100995041110104504111010150411100885041110106504111009050411100935041110110504111010850411101155041110112504111011650411101145041110107504111007450411101025041110111504111011350411100985041110100504111007150411100735041110117504111012350411101225041110124504111012550411101265041110109504111012750411101205041110129504111013050411101345041110128504111013550411101435041110136504111013750411101215041110140
- Serial Numbers
- Amount recalled
- 273 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
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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