Device product
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Z-1081-2024
Product summary
- Event
- Event 93807
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 80 kits
- Official record key
device-enforcement:Z-1081-2024
Official wording
Reason: Sterility assurance for saline included in surgical kits cannot be guaranteed.
Code information: UDI: B098AMS129470/ Lot #s: 192389 and 194805
Distribution pattern: US: FL, IL, CA OUS: None
Derived failure modes
-
Unknown
Sterility assurance for saline included in surgical kits cannot be guaranteed.