Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRA
Pending LLM rewrite. Source: FDA_DEVICE Z-2276-2026.
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
- Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P
- 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 (20)
- 1. Material: 333867
- UDI-DI Primary/Unit of Use: 4046964180842/4046964180835
- Batch Numbers: 0061965993
- 0061968406
- 0061971306
- 0061971487
- 0061978629
- 0061978630
- 2. Material: 333862
- UDI-DI Primary/Unit of Use: 4046964180743/4046964180736
- Batch Numbers: 0061947858
- 0061954126
- 0061970779
- 0061970781
- 0061970783
- 3. Material: 332607
- UDI-DI Primary/Unit of Use: 4046964558757/4046964558740
- Batch Number: 0061976109
- 4. Material: 333868
- UDI-DI Primary/Unit of Use: 4046964180866/4046964180859
Distribution
Distributed nationwide across the United States.
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