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Recall Observatory FDA recall evidence

Device product

STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

Z-1027-2013

March 22, 2013

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 64692
Status
Terminated
Classification
Class II
Quantity
1038 units
Official record key
device-enforcement:Z-1027-2013

Official wording

Reason: The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

Code information: Codes: 10217 10201-002 10201 10202-001

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.