Medline Kits Containing Bupivacaine Hydrochloride Recalled Due to Quality and Efficacy Concerns
Medline Industries, LP is recalling specific Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, which is the highest level of severity.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP. The affected products include BLOCK TRAY (SKU DYNJRA1181C) and SPINAL BLOCK 25G WHTCRE 5S BU (SKU DYNJRA1860).
The recall was initiated due to quality issues involving microbiology testing data integrity concerns and reported complaints regarding the efficacy of the product.
Distribution of the affected kits was worldwide, including US nationwide distribution, the US Territory of Virgin Islands, and the countries of Bahamas, Panama, and Barbados.
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 — Injection Kits
- Affected units
- 270
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
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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