[pending] Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPI
Pending LLM rewrite. Source: FDA_DEVICE Z-2236-2026.
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) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline
- 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 (20)
- Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each
- 40889942879237 case
- Lot Number 26BBJ392
- Lot Number 26ABS354
- Lot Number 25LBC413
- Lot Number 25IBK142
- Lot Number 25FBD584
- Lot Number 25BBK828
- Lot Number 24FBT398
- Lot Number 24BBR608
- Lot Number 23JBB581
- Lot Number 23IBQ010
- Lot Number 23HBM569
- Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each
- 40889942935865 case
- Lot Number 26AMK346
- Lot Number 25KMG102
- Lot Number 25JMA641
- Lot Number 25GMC349
- Lot Number 25DMG474
Distribution
Distributed nationwide across the United States.
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