Medline Industries, LP: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU D
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
- Recall initiated
- 2026-04-10
- Code info
- Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.
- Product quantity
- 4370 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98837
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