FDA Early Alert: Fluid Delivery Set Issue from Medline

Dear AHVAP Members and Partners:

This update is being provided to you as requested by the FDA. Make sure to access the full AHVAP Emergency Supply Chain Resource Center for updated tools, resources, and clinical practice recommendations.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

The FDA is aware that Medline has issued a letter to affected health care 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.

What to Do

• 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 here.
  • 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.

Reason for Early Alert

Medline identified Fluid Delivery Sets that were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber. 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.

Device Use

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.

Contact Information

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

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.

We encourage all AHVAP members to visit our Emergency Supply Chain Disruption Resource Center for the most up-to-date information. In addition, AHVAP's webinar from earlier today is now available on this website as well. 

To view the full FDA communication, visit the FDA's posting here. 

Team AHVAP