Windstone Medical Packaging, Inc.: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Recall initiated
- 2026-06-17
- Code info
- UDI/DI B098AMS13683A0, Lot Number 230451
- Product quantity
- 15 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Billings
- State
- MT
- Country
- United States
- Event id
- 99347
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