FDA Issues Early Alert on Medline Fluid Delivery Sets

Jan. 3, 2025
Certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits should be removed from use due to a potential high-risk issue.

On Dec. 30, the FDA posted an announcement that it is aware that Medline has issued a letter to affected healthcare providers recommending certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits be removed from use related to a potentially high-risk device issue.

The announcement said, “On December 16, 2024, Medline sent all affected customers a Medical Device Recall letter recommending the following actions:

  • Immediately check your stock for the affected item number and the affected lot numbers listed above.
  • Confirm whether you received product with the incorrect white macro drip chamber. Fluid Delivery Sets with white macro drip chambers should be discarded. The image below shows the difference in drip chamber colors and should help in identifying impacted devices.
  • If you have received the correct Fluid Delivery Set with a grey micro drip chamber, the product can be safely used.
  • Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.”

According to the FDA, the reason for the early alert is Medline’s identification of Fluid Delivery Sets that were not assembled correctly with a white macro dip chamber vs. the required gray micro drip chamber.

“The macro drip chamber delivers three times more fluid per drop than the micro drip chamber,” the announcement added. “As a result, using a Fluid Delivery Set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling (edema), shortness of breath, increased blood pressure, and/or death.”

Medline has not reported any injuries associated with this issue.

These fluid delivery sets with drip chambers are provided as components convenience kits. Fluid delivery sets prevent air from entering into the IV tubing and regulate the solution's flow rate.

 

About the Author

Janette Wider | Editor-in-Chief

Janette Wider is Editor-in-Chief for Healthcare Purchasing News.