Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x
Pending LLM rewrite. Source: FDA_DEVICE Z-2277-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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); Spin
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 1. Material: 333201
- UDI-DI Primary/Unit of Use: 4046964179365/4046964179358
- Batch Number: 0061976152
- 2. Material: 333211
- UDI-DI Primary/Unit of Use: 4046964179389/4046964179372
- Batch numbers: 0061965729
- 0061971323
- 0061972572
- 3. Material: 333231
- UDI-DI Primary/Unit of Use: 4046964179488/4046964179471
- Batch Number: 0061978177
Distribution
Distributed nationwide across the United States.
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