3M Steri-Vac Gas Sterilizer/Aerator recall
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Why was 3M Steri-Vac Gas Sterilizer/Aerator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
- Product
- 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 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.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)