B Braun Medical Inc: Spinal Anesthesia Kit
Recall Summary B. Braun Medical Inc is recalling Design Options Spinal Trays distributed nationwide to hospitals and medical centers. The recall was initiated because of potential quality issues with Bupivacaine Hydrochloride in Dextrose Injection, a medication component supplied by the manufacturer Huons Co, Ltd. The affected trays were used for spinal anesthesia procedures and were distributed across all U.S. states.
- Recalling firm
- B Braun Medical Inc
- Product
- Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL...
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/386ac552-8f2b-410b-be95-c112cd450023