FDA recall Z-0507-2024
Fresenius Medical Care Holdings, Inc. · Class II · device
Product
Stay Safe Cap
Reason for recall
Updating the labeling to include additional warnings and contraindications for potential side effects.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-10-10
- Report date
- 2023-12-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2024