AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Nu
Summary
The FDA issued a Class II for AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred by Windstone Medical Packaging, Inc.. Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Li.
Details
Source
Device Recall
External ID
Z-2813-2026
Action Date
2026-08-05
Status
Ongoing
Category
device
Product Description
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.
Lot/Code Info: Part Number AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot Numbers: 229846; Part Number AMS11314A, UDI/DI B098AMS11314A0; Lot Numbers: 216803, 240843; Part Number AMS11910A, UDI/DI B098AMS11910A0; Lot Numbers: 230645, 231078; Part Number AMS12171, UDI/DI B098AMS121710; Lot Numbers: 230958, 231238, 241232; Part Number AMS12219A, UDI/DI B098AMS12219A0; Lot Numbers: 217313; Part Number AMS12381B, UDI/DI B098AMS12381B0; Lot Numbers: 230948.
Quantity Affected: 580 kits
Reason for Recall
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 device recalls issued in the same week, part of 341 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2813-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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