B Braun Medical Inc — Class I: Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan
B Braun Medical Inc has initiated a Class I recall for specific Spinocan Spinal Needle procedure kits due to quality issues identified at the manufacturing facility of the included drug component, Bupivacaine Hydrochloride. The drug manufacturer, Huon Co, Ltd., issued a voluntary recall following an FDA inspection.
This affects clinical sites utilizing Spinocan 22, 25, and 26 Gauge Spinal Needle trays (specific material numbers 333201, 333211, and 333231) and departments responsible for medical device kitting and supplier qualified lists.
A Class I designation indicates that the FDA considers the defect to have a high potential for serious adverse health consequences or death. This case highlights the regulatory risk inherent in procedure kits where a sub-component (in this case, a drug) faces enforcement action, necessitating a recall of the entire finished device configuration. Quality management systems must account for the downstream impact of supplier-level manufacturing failures.
Regulatory and QA teams should immediately identify and quarantine affected Spinocan kits by material number. Procurement and supplier quality teams should evaluate the impact of the Huon Co, Ltd. recall on other potential kit configurations or inventories.
Class I. Reason: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.. Product: Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231). Firm: B Braun Medical Inc (Bethlehem PA United States). Status: Ongoing.
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