FDA recall Z-1082-2024
Windstone Medical Packaging, Inc. · Class I · device
Product
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Reason for recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Distribution
US: FL, IL, CA OUS: None
Key facts
- Status
- Ongoing
- Initiation date
- 2023-12-22
- Report date
- 2024-02-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Billings, MT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1082-2024