Recall Z-2815-2026— Windstone Medical Packaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461. Reason: Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-17
- Firm location
- Billings, MT, United States
Product description
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Reason for recall
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Data sourced from openFDA. This site is unofficial and independent of the FDA.