[pending] Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINA
Pending LLM rewrite. Source: FDA_DEVICE Z-2233-2026.
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 TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL T
- 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 SKU DYNJRA0245: UDI/DI 10884389573488 each
- 40884389573489 case
- Lot Number 26AMH714
- Lot Number 26AMF179
- Lot Number 25IMI476
- Lot Number 25GME934
- Lot Number 24JMA156
- Lot Number 24IMG162
- Lot Number 23IBG784
- Lot Number 23HBG512
- Lot Number 23HBA325
- Medline SKU DYNJRA0555: UDI/DI 10888277270923 each
- 40888277270924 case
- Lot Number 26AMK307
- Lot Number 25LME383
- Lot Number 25JMJ632
- Lot Number 25IMI508
- Lot Number 25IMB093
- Lot Number 25GMB270
- Lot Number 25EMD040
Distribution
Distributed nationwide across the United States.
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