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 Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injections.
Affected devices:
What to Do
Do not use Lidocaine Hydrochloride and Bupivacaine Hydrochloride included in affected kits. Check your stock for convenience kits containing Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injections and quarantine until over-labels are provided. All remaining components within the kits may continue to be used.
May 6, 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 Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection from certain convenience kits. Huons Co., Ltd. initiated a recall of Lidocaine Hydrochloride Injection and Bupivacaine HCL in Dextrose Injection following a recent FDA inspection of its manufacturing facility, which identified quality issues. Use of lidocaine and bupivacaine product with reduced anesthetic effectiveness may result in ineffective pain control, procedural discomfort, or repeat or delayed treatment.
As of May 20, 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 [email protected].
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
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.