Reported Nov 20, 2013 · Terminated
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
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. Used to sterilize heat and moisture sensitive reusable medical devices
- Lot codes and dates
- Batch
1,104 of 1,104 codes
104107001910410800591041080056104108005810410800551041080064104108006310410800571041080060104107002310410700221041080069104108007010410800661041080068104108007210410800731041080082104108007710410800611041080074104108007610410800781041080079104108008110410800871041080071104108009310410800801041080095104108009010410800891041080088104108009710410800981041080091104108009910410801001041080101104108009610410801591041080103104108010210410801041041080160104108016710410801721041080168104108016910410801741041070049104107005110410700481041080083104108008610410801651041080173104108017510410801641041080163
- Batch
- Amount recalled
- 2106 units total (1224 units in US)
Where it was sold
Why it was recalled
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
This product could cause temporary or reversible health problems — stop using it.
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