AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Moderate severity rating.
Plain-English summary
Windstone Medical Packaging, Inc. has issued a recall for specific AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits. These kits contain Elevaris Lidocaine HCl injection USP.
The recall was initiated due to supplier quality issues identified by Elevaris Medical Devices Inc.
Affected products include the following part numbers and lot numbers: - Nerve Block Tray - RX (Part Number AMS13975A): Lot Numbers 230376, 241103 - Universal Block Tray- RX (Part Number AMS2009): Lot Numbers 216938, 240939 - Nerve Block Tray - RX (Part Number AMS3224): Lot Number 231314
Distribution was nationwide across the United States in several states, including AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- supplier-quality-issues
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Part Number AMS13975A
- UDI/DI B098AMS13975A0
- Lot Numbers: 230376
- 241103
- Part Number AMS2009
- UDI/DI B098AMS20090
- Lot Numbers: 216938
- 240939
- Part Number AMS3224
- UDI/DI B098AMS32240
- Lot Numbers: 231314.
Distribution
Distributed nationwide across the United States.
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