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.
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: 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.
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