Medical Convenience Kits Recalled Due to Lidocaine Supplier Quality Issues
Windstone Medical Packaging is recalling 24 AMS Heart Cath Tray convenience kits containing Elevaris Lidocaine HCl injection because the lidocaine was 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 source reports no illnesses or injuries. Under the rubric, Class II without hospitalization reports corresponds to Moderate.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 24 AMS Aligned Medical Solutions medical convenience kits labeled as Heart Cath Tray - RX, Part Number DDS1159B. The affected kits are identified by UDI/DI B098DDS1159B0 and Lot Number 214412. They were distributed nationwide in 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. recalled due to supplier quality issues. The FDA has classified this as a Class II recall. The notice does not specify the nature of the quality issue and does not report any illnesses or injuries.
The recall notice does not include specific consumer instructions. Patients and providers who have the affected lot should check the product labeling and follow any guidance from the recalling firm or their healthcare provider.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 24
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 B098DDS1159B0
- Lot Numbers: 214412.
Distribution
Part of a larger recall action
This product is one of 8 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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