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Windstone Medical Packaging, Inc.: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461

Medical DevicesSource: FDA (device) · Date: 2026-08-05

Read the official notice at FDA (device) →

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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: Angio Pack - RX, Part Number AMS9461
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 B098AMS94610, Lot Numbers: 230658, 231173.
Product quantity
60 kits
Voluntary mandated
Voluntary: Firm initiated
City
Billings
State
MT
Country
United States
Event id
99347
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