B Braun Medical Inc: 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); S...
B Braun Medical Inc is recalling Spinocan spinal needle kits in three gauge sizes that contain Bupivacaine 0.75% with Dextrose 8.25% due to potential quality issues with the Bupivacaine component supplied by manufacturer Huons Co, Ltd. The recall affects products distributed nationwide across all U.S. states. This is a Class I recall, the most serious classification.
- Recalling firm
- B Braun Medical Inc
- Product
- 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);
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/df505a49-0b80-47e7-b1cf-733fc416a40a