Recall Z-3138-2026— Windstone Medical Packaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B. Reason: 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..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-29
- Firm location
- Billings, MT, United States
Product description
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.