[pending] Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL
Pending LLM rewrite. Source: FDA_DEVICE Z-2237-2026.
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 ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Ki
- 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 DYNJRA0102A: UDI/DI 10884389459003 each
- 40884389459004 case
- Lot Number 26ABG838
- Lot Number 25JBR222
- Lot Number 25IBJ307
- Lot Number 25EBR346
- Lot Number 24LDB145
- Lot Number 24FDB896
- Medline Kit SKU DYNJRA0143B: UDI/DI 10195327125820 each
- 40195327125821 case
- Lot Number 24ABQ670
- Medline Kit SKU DYNJRA0205B: UDI/DI 10195327472344 each
- 40195327472345 case
- Lot Number 24KMD212
- Medline Kit SKU DYNJRA0255B: UDI/DI 10195327282042 each
- 40195327282043 case
- Lot Number 26CMG585
- Lot Number 26BMK211
- Lot Number 25JMC385
- Lot Number 25IMB105
Distribution
Distributed nationwide across the United States.
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