Spinal Needle procedure kits: Material Description recall
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY…
Why was Spinal Needle procedure kits: Material Description recalled?
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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; Batch Numbers: 0061958120, 0061958276, 0061960474, 0061960475, 0061960476, 0061960477, 0061960478, 0061965732, 0061965733, 0061965734, 0061965735, 0061965736, 0061965737, 0061965738, 0061965739, 0061965740, 0061965741, 0061965743, 0061969393, 0061969394, 0061969395, 0061969397, 0061969438, 0061969439, 0061969440, 0061969441, 0061970674, 0061970675, 0061970726, 0061970727, 0061970729, 0061970730, 0061971108, 0061975011, 0061975012, 0061975013, 0061975014, 0061975015, 0061975016, 0061975017, 0061975018, 0061976996, 0061976997, 0061976998, 0061976999, 0061979852; 5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295; 6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099; 7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124, 0061954125, 0061954130, 0061954131, 0061954132, 0061954134, 0061954135, 0061960457, 0061960458, 0061960459, 0061960460, 0061960461, 0061965687, 0061965688, 0061965689, 0061967621, 0061967623, 0061967624, 0061967626, 0061969508, 0061969986, 0061970102, 0061970104, 0061970105, 0061970106, 0061970107, 0061970109, 0061970110, 0061970860, 0061970861, 0061970863, 0061970864, 0061970866, 0061970867, 0061971261, 0061971262, 0061971263, 0061971264, 0061971265, 0061971266, 0061971268, 0061971269, 0061972812, 0061972813, 0061974198, 0061974199, 0061974200, 0061974201, 0061974247, 0061974248, 0061974249, 0061974250, 0061974251, 0061974253, 0061974559, 0061974562, 0061974563, 0061974564, 0061974569, 0061975004, 0061975005, 0061975006, 0061975007, 0061975008, 0061975009, 0061975810, 0061976903, 0061976904, 0061976905, 0061976906, 0061976908, 0061976909, 0061976910, 0061976911, 0061976912, 0061976913, 0061976914, 0061976915, 0061979785, 0061979786, 0061979787, 0061979788, 0061979790, 0061979791, 0062019490;
- Product
- Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY…
- Recalling firm
- B Braun Medical Inc
- Quantity
- 582,030 units
- Distribution
- US Nationwide distribution.
- Recall date
- June 10, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)