The Recall Desk
HighFDA (Devices)·Z-2224-2016·Announced 2016-07-27

WalkMed Recalls IV Administration Sets Due to Particulate Presence

WalkMed Infusion is voluntarily recalling specific lots of 90-inch 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 injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

WalkMed Infusion, LLC is conducting a voluntary field action to recall specific lots of T090-000V 90" 20 Drop IV Administration Sets with Needlefree Y-Sites. The recall is being issued due to the potential presence of particulate matter in or on the administration sets. The affected product is packaged in Tyvek pouches, with 50 pouches per case.

The recall involves 3,342 cases of the product. The affected lot numbers are 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, and 1506064D. 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.

These devices are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above and stop using the affected products. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. 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
3,342

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 (18)

  • Product Number: 020-300198. Lot Number: 1406083
  • 1406084
  • 1406085
  • 1406086
  • 1407014
  • 1407015
  • 1407118
  • 1407119
  • 1408129
  • 1408130
  • 1410072D
  • 1410073D
  • 1412059D
  • 1501062D
  • 1501106D
  • 1503048D
  • 1503049D
  • 1506064D

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 →

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