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  5. Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail
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Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail

This recall involves removing certain devices 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.

The devices described in this recall are related to the ongoing evaluation announced in the FDA’s safety communication: Evaluating Plastic Syringes Made in China for Potential Device Failures

Affected Product

What to Do

  • Do not use syringes from impacted convenience kits.
  • Watch closely for leaks, breakage, or any other problem if no alternative syringes are available. 

On April 18, 2024, Medline Industries, LP, sent all affected customers an Immediate Action Required Recall letter recommending the following actions: 

  • Immediately check stock for affected item numbers and lot numbers.
  • Dispose of any unused product--do not return it to Medline Industries. 
  • Complete a response form at: https://recalls.medline.com.
  • Use Recall Reference #: R-24-075-FGX and the Recall Code provided in the notification.
  • List quantity of affected product in inventory, even if the quantity is zero.
  • Notify any company or individual who received this product through distribution, resale, or transfer.

Reason for Recall

Medline Industries, LP, is recalling Convenience Kits because they contain syringes that may leak, break, or have other quality issues. The syringes were manufactured by Jiangsu Shenli and Jiangsu Caina, which are affected by an FDA Safety Alert issued on March 19, 2024.

The use of affected product may cause serious adverse health consequences, including infections or blood vessel blockages (embolization) from debris in the syringes, and death.

There have been no reported injuries and no reports of death.

Device Use

Convenience kits include two or more different medical devices packaged because they are frequently used together in a health care setting.

Medline Industries, LP, Convenience Kits are used for procedures including: peripheral nerve block/catheter insertion, epidural and spinal trays, cardiac catheterization trays, vascular (blood vessel) access trays, kidney (nephrology) kits, and basic diagnostic trays. The syringes within the convenience kits are used to deliver medications and fluids or as “control” syringes to assist with finding the space between vertebrae called the epidural space.

Contact Information

Customers in the U.S. with questions about this recall should contact Medline’s Recall Department at 866-359-1704 or recalls@medline.com.

Additional FDA Resources

Additional Company Resources

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 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.

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