[pending] Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOC
Pending LLM rewrite. Source: FDA_DEVICE Z-2234-2026.
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: Pending LLM scoring against the rubric.
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) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.
- 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 (7)
- Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each
- 40193489457606 case
- Lot Number 25DMF105
- Lot Number 25CMB575
- Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each
- 40195327008414 case
- Lot Number 24DMB099.
Distribution
Distributed nationwide across the United States.
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