Spinocan 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); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231);
Recall
- Recall Number
- Z-2277-2026
- Event Number
- 98838
- Firm
- B Braun Medical Inc
- FEI Number
- 2521402
- Product Code
- OFU
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 6, 2026
- Posted
- June 3, 2026
- Address
- 824 12th Ave, Bethlehem, PA, 18018-3524
Description
Spinocan 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); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231);
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
On May 6, 2026, URGENT MEDICAL DEVICE RECALL were sent to customers. Actions to be taken: - Check inventory for affected product and return to B Braun. The return process will begin when B Braun received the Acknowledgement Form.) - If you are a distributor and have further distributed the product, please forward this notice to your consignees. This recall is to be extended to the hospital/healthcare facility level. Should there be any questions, comments, or concerns, please feel free to contact us via email at [email protected] or via phone at 844-903-6417 Monday through Friday, 8:00am-5:00pm EST.
US Nationwide distribution.
16,080 units