Medline Industries, LP — Class I: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:
Medline Industries, LP is recalling specific spinal block and tray kits because they contain Huons Co. Bupivacaine Hydrochloride in Dextrose Injection, which was recalled for microbiology data integrity concerns and efficacy complaints. This has been classified by the FDA as a Class I recall, the most serious category.
This affects Medline Industries, LP, healthcare facilities utilizing kitted spinal block trays (SKUs DYNJRA1181C and DYNJRA1860), and quality/supply chain professionals responsible for component sourcing and kitting operations.
A Class I designation indicates that the FDA believes there is a reasonable probability of serious adverse health consequences or death. The mention of 'microbiology testing data integrity concerns' suggests significant gaps in the primary manufacturer's sterile assurance or laboratory documentation, which undermines the safety profile of the entire kit. This case highlights the regulatory risk for kit manufacturers when a sub-component (in this case, a drug constituent) fails quality standards.
QA teams should immediately verify if these specific kit SKUs are in inventory and quarantine them. Procurement and Supplier Quality departments should evaluate the impact of the Huons Co. bupivacaine recall on other kitted products. Regulatory teams should document the traceability between the drug component failure and the finished device kit for reporting purposes.
Class I. Reason: 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.. 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.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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