The Recall Desk
HighFDA (Devices)·Z-2233-2016·Announced 2016-07-27

WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence

WalkMed Infusion is voluntarily recalling Triton 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) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product without reported injury.

Plain-English summary

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

The affected product is the T100-120F with a 1.2 micron filter and FP Clip, packaged in a Tyvek pouch 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 covers 295 cases distributed nationwide in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

The affected product number is 020-300650. The specific lot numbers involved are 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, and 1506052D. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
T100-120F with 1.2 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
295

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 (6)

  • Product Number: 020-300650. Lot Number: 1412070D
  • 1502055D
  • 1503039D
  • 1505047D
  • 1506051D
  • 1506052D

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 →

Same hazard · particulate contamination

See all →