Medical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection
Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries in the source; the product is an injectable medication kit, so the High rubric criterion for risk-of-harm products where injury has not yet been reported applies.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 15 AMS Aligned Medical Solutions medical convenience kits labeled as SPINAL KIT, Part Number AMS13683A. The affected kits are identified by UDI/DI B098AMS13683A0 and Lot Number 230451. The kits 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 recall as Class II.
The recall applies only to the specific lot listed above. Consumers can identify affected kits by matching the UDI/DI and lot number. The recall notice does not include additional consumer instructions.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- drug-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 B098AMS13683A0
- Lot Number 230451
Distribution
Distributed nationwide across the United States.
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