The Recall Desk
HighFDA (Devices)·Z-2232-2016·Announced 2016-07-27

WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence

WalkMed Infusion is voluntarily recalling Triton Administration Sets because they may contain particulate matter. The recall affects 383 cases distributed nationwide.

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) where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products without reported injury.

Plain-English summary

WalkMed Infusion, LLC is conducting a voluntary field action to recall multiple Triton Administration Sets. The recall is being issued due to the potential presence of particulate matter in or on the administration sets. The affected product is the T100-022F with a 0.22 micron filter and FP Clip, packaged in Tyvek pouches with 50 pouches per case. These devices are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

The recall involves 383 total cases. 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. The specific product number is 020-300649, and the affected lot numbers are 1412061D, 1503069D, 1505046D, and 1506087D.

Healthcare facilities and consumers should stop using the affected administration sets and contact WalkMed Infusion, LLC for further instructions or a return. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
T100-022F with 0.22 micron filter and FP Clip. 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
383

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 (4)

  • Product Number: 020-300649. Lot Number: 1412061D
  • 1503069D
  • 1505046D
  • 1506087D

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 →