Recall Z-1563-2016 ยท FLF Sterilizer, Ethylene-Oxide Gas
3M Company - Health Care Business
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
| Date | Jan 22, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957. |
| 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. |
| FDA record | Open on fda.gov |