[pending] Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material
Pending LLM rewrite. Source: FDA_DEVICE Z-2278-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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