The Recall Desk
HighFDA (Devices)·Z-1807-2024·Announced 2024-05-22

Medline Namic Fluid Delivery Set Recalled for Lack of Sterility Assurance

Medline Industries is recalling Namic Fluid Delivery Sets (lot 0000113381) because they lack sterility assurance, which could allow contamination during medical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a risk-of-harm hazard (lack of sterility assurance in a fluid delivery set used in medical procedures). No illnesses or injuries are reported in the source material.

Plain-English summary

Medline Industries, LP is recalling Namic Fluid Delivery Sets (REF 91300040) due to a lack of sterility assurance. The affected product units have UDI/DI 20193489069096 for the box and 10193489069099 for individual units, with lot number 0000113381.

The recalled sets were distributed nationwide across Alabama, Florida, Kentucky, Mississippi, Texas, Washington, Wisconsin, North Carolina, Virginia, California, South Dakota, Tennessee, Georgia, and Pennsylvania. Approximately 50 units were affected.

A fluid delivery set lacking sterility assurance may not maintain proper sterile conditions during medical procedures, potentially exposing patients to microbial contamination and infection. Customers and healthcare facilities that received this product should stop using it and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Namic FLUID DELIVERY SET, REF 91300040
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-assurance
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 20193489069096 (box)
  • 10193489069099 (unit)
  • Lot Numbers: 0000113381

Distribution

Distributed nationwide across the United States.