Medline spinal anesthetic kits recalled for quality and efficacy concerns
Medline Industries is recalling 4,370 spinal anesthetic kits due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This product is classified as FDA Class I. FDA Class I is identified in the severity rubric as a criterion for Critical severity.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine Hydrochloride in Dextrose Injection, USP, labeled as SPINAL BLOCK 22G QUINCKE 5S BU (SKU DYNJRA9026). The recall affects 4,370 kits.
The kits were recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. These quality issues may affect the reliability and safety of the anesthetic for spinal blocks.
The affected kits were distributed worldwide, including the US, Virgin Islands, Bahamas, Panama, and Barbados. The affected lot numbers are 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, and 24FBJ505.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
- Manufacturer
- Medline Industries, LP
- Hazard
- efficacy-failure
- sterility-concern
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 (9)
- Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each
- 40884389285689
- case
- Lot Numbers: 26BBD235
- 26ABB534
- 25DBT837
- 25CBH118
- 24FBT403
- 24FBJ505.
Distribution
Distributed nationwide across the United States.
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