Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Product

The FDA is aware that Medline has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use by removing included Bupivacaine Hydrochloride in Dextrose Injections.

Affected devices:

• Medline Convenience Kits
• Full List of Affected Product

What to Do

Do not use Bupivacaine Hydrochloride included in affected kits. Check your stock for convenience kits containing Bupivacaine Hydrochloride in Dextrose Injections and quarantine until over-labels are provided. All remaining components within the kits may continue to be used.

On April 10, Medline sent all affected customers a letter recommending the following actions:

• Immediately check your stock for the affected item and lot numbers. Quarantine all affected product.
• Complete the recall response form to receive over-labels to place on affected inventory.
• Place over-labels on the affected product. The labels provide instructions for staff to remove and discard the affected component prior to using the kit.
• If you have distributed, resold, or transferred affected products to other companies or individuals, notify them of this recall.

Reason for Correction

Medline Industries is removing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP from certain convenience kits. Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP following a recent FDA inspection of its manufacturing facility, which identified quality issues. Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.

As of April 10, Medline has reported no serious injuries and deaths associated with this issue.

Device Use

Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.

Contact Information

Customers in the U.S. with questions about this recall should contact Medline Industries at 1-866-359-1704, or via email at recalls@medline.com.

Additional FDA Resources:

• FDA’s Enforcement Report
• Medical Device Recall Database
• Huons Co., Ltd. Bupivacaine Recall: FDA Enforcement Report

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.