FDA-Device2026-07-29Class IPROCESSING DEFECT

Medline Anterior Hip Kit recalled for quality issues in anesthetic component

Medline Anterior Hip Kit recalled for anesthetic quality issues

Medline Industries is recalling specific Anterior Hip surgical kits (SKU DYNJ909640G) that contain a B. Braun convenience kit with Bupivacaine Hydrochloride in Dextrose Injection. The anesthetic component was manufactured by Huons Co, Ltd., which issued a voluntary recall due to quality concerns with the injectable drug.

  • If you have this kit (Lot 25DBF430, UDI 10198459280559), stop using it immediately.
  • Contact Medline Industries or your supplier for instructions on return or replacement.
  • Verify lot number and UDI on your packaging before use.
Hazard

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.

Sold states
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Affected count
60 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2747-2026

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