FDA-Device2024-02-28Class I
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, 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
1,528 units
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2024Don't want to check this manually?
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