FDA-Device2016-05-04Class II
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
3M Company - Health Care Business
Hazard
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.
Sold states
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.
Affected count
74 valves
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
Products
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2016Don't want to check this manually?
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