Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material
Pending LLM rewrite. Source: FDA_DEVICE Z-2278-2026.
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
- Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (
- 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: 560074
- UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859
- Batch Numbers: 0061960383
- 0061972565
- 2. Material: 560214
- UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054
- Batch Numbers: 0061971346
- 0061977782
- 3. Material: 560272
- UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085
- Batch Numbers: 0061960367
- 0061971330
- 4. Material: 560327
- UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207
- Batch Numbers: 0061960420
- 0061977751
- 5. Material: 560394
- UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405
- Batch Numbers: 0061964747
- 0061976985
Distribution
Distributed nationwide across the United States.
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