Device 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.
Z-0403-2014
Product summary
- Event
- Event 66815
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 4,381 units
- Official record key
device-enforcement:Z-0403-2014
Official wording
Reason: 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.
Code information: Please refer to consignee list
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.