Reported Jan 22, 2014 · Terminated
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low…
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?
- STERRAD 50 Sterilization System
- Product Code10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments
- Lot codes and dates
- not available
- Amount recalled
- 233 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
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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