Becton Dickinson & Company — Class I: BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacai
Becton Dickinson & Company has initiated a Class I recall for specific Spinal Trays containing Bupivacaine Hydrochloride in Dextrose Injection. This actions stems from a sub-recall initiated after an FDA inspection identified quality deficiencies and acceptance testing failures at the drug manufacturer, Huons Co, Ltd.
Becton Dickinson & Company, healthcare facilities utilizing BD Spinal Trays (Catalog Number 405645), and quality/procurement departments responsible for anesthesia supplies.
A Class I designation indicates the FDA believes the product could cause serious adverse health consequences or death. This case highlights the regulatory risk of convenience kits where a component manufacturer's facility-level quality failures (specifically in acceptance testing) necessitate a recall of the finished medical device assembly.
QA and Supply Chain teams should immediately identify and quarantine affected lots of catalog number 405645. Regulatory departments should review agreements with sub-component suppliers to ensure that quality failures at the primary manufacturer level trigger immediate reporting and containment protocols.
Class I. Reason: This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.. Product: BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.. Firm: Becton Dickinson & Company (Franklin Lakes NJ United States). Status: Ongoing.
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