3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Reported: May 4, 2016 Initiated: January 22, 2016 #Z-1563-2016
Product Description
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Reason for Recall
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.
Details
- Recalling Firm
- 3M Company - Health Care Business
- Units Affected
- 74 valves
- Distribution
- 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.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.. Recalled by 3M Company - Health Care Business. Units affected: 74 valves.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1563-2016.
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