Serious riskFDA DeviceClass I

Medline anterior hip kits recalled for bupivacaine 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.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Sold in
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Made for
Adults (18 years to 120 years)

This recall covers 3 products — see all of them.

Details

Units affected
60 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-2747-2026

In the FDA's words

Description
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G 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. UDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430 Distribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ. Affected quantity: 60 kits
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.

3 products in this recall

Medline convenience kits recalled for bupivacaine quality issues

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

The agency lists each product separately. Check every one you might have.

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