FDA DeviceClass INotable

FDA Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material

Date: 2026-06-10
Brand: B Braun Medical Inc
Category: Medical Device
FDA Class: Class I

Description

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.

Hazard

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.

Remedy

104,720 units

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