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Recall Observatory FDA recall evidence

Device product

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

Z-1563-2016

January 22, 2016

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 73117
Status
Terminated
Classification
Class II
Quantity
74 valves
Official record key
device-enforcement:Z-1563-2016

Official wording

Reason: 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.

Code information: Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147

Distribution pattern: AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled