Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling 100 AMS convenience kits labeled Block Tray - RX, Part Number AMS12414, because they contain Elevaris Lidocaine HCl injection recalled for 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 FDA classified this recall as Class II, and the notice does not report any illnesses, injuries, or hospitalizations. This aligns with the Moderate severity level under the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 100 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as Block Tray - RX, Part Number AMS12414. The affected kits have UDI/DI B098AMS124140 and Lot Number 230411. The kits were distributed nationwide in the U.S. 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, and WA.
The recall was issued because the kits contain Elevaris Lidocaine HCl injection USP, which Elevaris Medical Devices Inc. previously recalled due to supplier quality issues. The FDA has classified this recall as Class II.
Consumers who have an affected kit should verify the lot number and contact Windstone Medical Packaging, Inc. for further guidance. Healthcare providers and distributors should check their inventory for the recalled lot and follow the recall notice for next steps.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- supplier-quality-issue
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 (2)
- UDI/DI B098AMS124140
- Lot Numbers: 230411.
Distribution
Distributed nationwide across the United States.
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