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.