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Recall Observatory FDA recall evidence

Device product

STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Z-0044-2014

September 18, 2013

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 66317
Status
Terminated
Classification
Class II
Quantity
2,995 units
Official record key
device-enforcement:Z-0044-2014

Official wording

Reason: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.

Code information: Lot# 13F050, 13F051, 13F049

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.