The Recall Desk
HighFDA (Devices)·Z-2222-2016·Announced 2016-07-27

WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter in or on the devices.

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: The recall involves a medical device with a potential contamination hazard (particulate matter) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

WalkMed Infusion, LLC is conducting a voluntary field action to recall multiple lots of Triton Administration Sets. The recall is being issued because of the potential presence of particulate matter in or on the administration sets.

The affected product is the T030-000 30-inch 20 Drop IV Admin Secondary Set, which is used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. The product is packaged in a Tyvek pouch, with 50 pouches per case. A total of 2,453 cases are involved in this recall.

The affected lots are 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, and 1507011D. The product was distributed nationwide in the states of Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product
T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Affected units
2,453

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 (13)

  • Product Number: 020-300188. Lot Number: 1407012
  • 1407013
  • 1407504
  • 1408125
  • 1410069D
  • 1410070D
  • 1410071D
  • 1411106D
  • 1412002D
  • 1412113D
  • 1503120D
  • 1506053D
  • 1507011D

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 15 recalled by WalkMed Infusion, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →