Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN
Pending LLM rewrite. Source: FDA_DEVICE Z-2232-2026.
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) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND
- 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 DYNJRA1555: UDI/DI 10193489238723 each
- 40193489238724 case
- Lot Numbers: 25CLA724
- Lot Numbers: 25CLA306
- Medline SKU DYNJRA1817: UDI/DI 10193489942354 each
- 40193489942355 case
- Lot Numbers: 25JMH667
- Lot Numbers: 25JMC856
- Lot Numbers: 25JMA370
- Lot Numbers: 25IMI402
- Lot Numbers: 25HME985
- Lot Numbers: 25AMI063
- Lot Numbers: 24JMI488
- Lot Numbers: 24JMA113
- Lot Numbers: 23KMD776
- Medline SKU DYNJRA1920: UDI/DI 10195327111168 each
- 40195327111169 case
- Lot Numbers: 25FBQ144
- Medline SKU DYNJRA2013: UDI/DI 10195327212049 each
- 40195327212040 case
Distribution
Distributed nationwide across the United States.
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