Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
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 Medline convenience be corrected prior to continued use by removing components affected by the B. Braun Medical, Inc. recall. Affected devices:
- Medline Anterior Hip Kits
- Medline C-Section kits
- Medline MHCZ Total Knee Kits
- Medline Posterior Hip Kits
- Medline Total Hip Kits
- Medline Total Hip w/ Navigation No Syringe Kits
- Medline Total Hip - LF Kits
- Medline Total Joint Kits
- Medline Total Knee Kits
- Medline Total Knee Basic Kits
- Medline Total Knee w/ Navigation Kits
- Medline Total Knee W/ Navigation No Syringe Kits
- Medline Total Knee – LF Kits
What to Do
Identify and quarantine affected product. Place over-labels with instructions to remove and discard the affected component prior to using the kit on affected products.
On June 6, Medline sent all affected customers a letter recommending the following actions:
- Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.
- Complete and submit the recall response form to receive over-labels to place on affected inventory. The over-labels provide instructions for staff to remove and discard the affected component prior to using the kit.
- If you have further distributed the product, please forward this notice to your consignees.
Reason for Correction
Medline is correcting Medline kits containing B. Braun components that include 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 which can lead to emergency conversion to general anesthesia. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.
As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with this issue. As of June 19, Medline has not reported any additional serious injuries or deaths associated with this issue.
Device Use
Convenience Kits are two or more separate types of finished products packaged together for the convenience of the user. Kits (or trays) are often utilized in the surgical arena. Generally, the kits involved in this recall are used for pain management and regional anesthesia.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline at 866-359-1704 or recalls@medline.com.
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
- Upstream Related Recalls
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.