Class I

Medical Device Recall: Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

Windstone Medical Packaging, Inc. · December 22, 2023

Reason for Recall

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

Distribution

US: FL, IL, CA OUS: None

States Affected

CA, FL, IL

Quantity Affected

1,528 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1079-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Windstone Medical Packaging, Inc. Medical Device Recall: Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO | SafeCheck