Reported Dec 4, 2013 · Terminated
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer…
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 100NX
- Product Code10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices
- Lot codes and dates
- Please refer to consignee list
- Amount recalled
- Total 4,381 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 STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in 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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