Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANES
Pending LLM rewrite. Source: FDA_DEVICE Z-2231-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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 (10)
- Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each
- FI case
- Lot Numbers: 26CBA272
- Lot Numbers: 26ABS307
- Lot Numbers: 25HBE663
- Lot Numbers: 25FBA408
- Lot Numbers: 25CBG043
- Lot Numbers: 24FBT395
- Medline SKU DYNJRA2151: UDI/DI 10195327365400 each
- Lot Numbers: 24FBT396.
Distribution
Distributed nationwide across the United States.
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