Z-1563-2016 Class II Terminated
FDA device recall Z-1563-2016 was initiated by 3M Company - Health Care Business on Jan 22, 2016 and is designated Class II. 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… The recall status is terminated (terminated Aug 25, 2016). Affected quantity: 74 valves.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- Jan 22, 2016
- Termination Date
- Aug 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 valves
Product Description
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
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 Pattern
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.
Code Information
Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1563-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026