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 the components affected by the Huons Co., Ltd. recall. Affected devices:
| Product Description | Kit SKU | UDI/DI (each) | UDI/DI (case) | Lots |
|---|---|---|---|---|
| TOTAL KNEE CDS | CDS983930J | 10193489512298 | 40193489512299 | 25KBL209 |
| LISTON HIP CDS-LF | CDS984556L | 10195327554996 | 40195327554997 | 24JDC180 |
| LISTON HIP CDS-LF | CDS984556L | 10195327554996 | 40195327554997 | 24HDA321 |
| LISTON HIP CDS-LF | CDS984556M | 10198459180248 | 40198459180249 | 25ADB327 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 26EDA285 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 26DDA718 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 26BDB740 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 26ADB079 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 26ADA161 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 25KDB472 |
| LISTON HIP CDS-LF | CDS984556N | 10198459266621 | 40198459266622 | 25GDA213 |
| LISTON TOTAL KNEE-LF | CDSOPT590T | 10195327555009 | 40195327555000 | 24GDA740 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 26EDA279 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 26BDB734 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 26ADA474 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 25LDA001 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 25KDB325 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 25GDB517 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 25FDB017 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 25DDA155 |
| LISTON TOTAL KNEE-LF | CDSOPT590U | 10198459180255 | 40198459180256 | 24LDA248 |
| TOTAL KNEE PACK | DYNJ905162Q | 10198459235900 | 40198459235901 | 26CBD346 |
| TOTAL KNEE PACK | DYNJ905162Q | 10198459235900 | 40198459235901 | 25KBU219 |
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 June 8, 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 is issuing a recall for specific Medline Kits containing ICU Medical, Inc. pain management kits with Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP. 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 and emergency conversion to general anesthesia.
As of June 8, Medline, Medline has not reported any serious injuries or 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
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 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.
