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Recall Observatory FDA recall evidence

Device product

STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

Z-0744-2014

December 16, 2013

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 67043
Status
Terminated
Classification
Class II
Quantity
5584 units
Official record key
device-enforcement:Z-0744-2014

Official wording

Reason: 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.

Code information: not available

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.