The Recall Desk
HighFDA (Devices)·Z-2231-2016·Announced 2016-07-27

WalkMed Recalls IV Sets Due to Potential Particulate Presence

WalkMed Infusion is voluntarily recalling specific lots of Triton 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 risk of harm (particulate matter) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products.

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 due to the potential presence of particulate matter in or on the administration sets.

The affected product is the T100-000WF IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. These sets are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. The recall involves 2,198 cases, with 50 pouches per case. The affected lot numbers are 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, and 1508073D.

The affected products were 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 facilities and consumers should check their inventory for these specific lot numbers and stop using the affected sets.

The recalled product

Product
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow 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.
Manufacturer
WalkMed Infusion, LLC
Category
Medical Device — IV Administration Sets
Hazard
Affected units
2,198

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: 020-300644. Lot Number: 1406019
  • 1406020
  • 1407020
  • 1407021
  • 1407022
  • 1407120
  • 1407121
  • 1408133
  • 1501111D
  • 1506067D
  • 1507020D
  • 1507060D
  • 1508073D

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 →

Related recalls

Same manufacturer · WalkMed Infusion, LLC

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Same hazard · particulate matter

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