B Braun Medical Inc: Material Description (material Number) 24ga. Pencan Spinal Bup. Tray W/duraprep (333867); 25ga. Pencan Spinal Bup. Tray W/duraprep (333862); Govp24bk
Recall Summary B. Braun Medical Inc. is recalling multiple spinal anesthesia trays containing bupivacaine that were distributed nationwide. The recall was initiated by the manufacturer of the bupivacaine ingredient (Huons Co, Ltd.) due to potential quality issues with the medication. This is classified as a serious recall affecting healthcare facilities across all U.S. states.
- Recalling firm
- B Braun Medical Inc
- Product
- Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851);
- 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/ab962477-2f6d-4250-a058-7bd81d610952