FDA-Device2024-02-28Class I

Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

Windstone Medical Packaging, Inc.
Hazard

Sterility assurance for saline included in surgical kits cannot be guaranteed.

Sold states
US: FL, IL, CA OUS: None
Affected count
128 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1080-2024

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