3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
This recall has been terminated (originally issued January 22, 2016).
- Recall Initiated
- January 22, 2016
- Terminated
- August 25, 2016
- Recall Number
- Z-1563-2016
- Quantity
- 74 valves
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
Root Cause
Nonconforming Material/Component
Action Taken
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.