Recall record at a glance
| Official record | Z-1563-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | 3M Company - Health Care Business |
| Report date | May 4, 2016 |
| Recall initiation date | Jan 22, 2016 |
| Quantity | 74 valves |
| Location | Saint Paul, MN, United States |
Official product description
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Why the product was 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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