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3M Company - Health Care Business recalls 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Recalled May 4, 2016 · FDA recall Z-1563-2016 · 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. · FDA Class II
Units
74 valves
Sold at
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.
Description
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.
Product
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →