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Advanced Sterilization Products recalls STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer use
Recalled December 4, 2013 · FDA recall Z-0403-2014 · Advanced Sterilization Products
Hazard
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. · FDA Class II
Units
Total 4,381 units
Sold at
Nationwide Distribution
Description
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.
Product
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Manufacturer(s)
Advanced Sterilization Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →