Avid Medical, Inc.: Obstetrical Kit
Recall Summary B. Braun Medical is recalling spinal anesthesia convenience kits that contain Bupivacaine Hydrochloride in Dextrose Injection made by Huons due to a component issue with the Bupivacaine product. The recall affects medical facilities and healthcare providers who use these kits for spinal anesthesia procedures. The recall is being issued because the Bupivacaine component itself was previously recalled.
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11
- Reason
- A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7b1380c3-0c76-4be2-a8d6-9140a9c42ab8