Class II

Medical Device Recall: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

Windstone Medical Packaging, Inc. · July 29, 2026

Reason for Recall

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

Distribution

US Nationwide distribution in the states of CA, GA, WA.

States Affected

NATIONWIDE

Quantity Affected

3,260 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3138-2026

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: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B | SafeCheck