FDAFDA · Food and drugs·Recall number Z-1563-2016
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Published May 4, 2016 · Recall initiated: January 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3M Company - Health Care Business
- Distributor
- 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.
- Lot
- Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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