Z-2748-2026 Class I Ongoing
FDA device recall Z-2748-2026 was initiated by Medline Industries, LP on June 5, 2026 and is designated Class I. Reason for recall: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n… The recall status is ongoing. Affected quantity: 56 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 kits
Product Description
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Reason for Recall
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Distribution Pattern
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Code Information
1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805.