Medline Spinal Block Kits Recalled Due to Quality and Efficacy Concerns
Medline Industries, LP is recalling 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 represents the highest level of risk.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU (Medline Kit SKU DYNJRA9026).
The recall was initiated due to quality issues, specifically involving microbiology testing data integrity concerns and reported complaints regarding the product's efficacy.
This recall affects approximately 4,370 kits distributed worldwide, including in the US Territory of the Virgin Islands and the countries of Bahamas, Panama, and Barbados. Affected lot numbers include 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
- Affected units
- 4,370
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
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.
See all 7 products in this recall →Related recalls
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