The Recall Desk
HighFDA (Devices)·Z-2223-2016·Announced 2016-07-27

WalkMed Recalls IV Administration Sets Due to Potential 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 is classified as FDA Class II, and the hazard involves potential particulate matter in a medical device used for intravenous administration, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

WalkMed Infusion, LLC is conducting a voluntary field action to recall specific lots of T090-000 90" 20 Drop IV Administration Sets. The recall is being issued due to the potential presence of particulate matter in or on the administration sets. These devices are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

The affected product is packaged in a Tyvek pouch, with 50 pouches per case. The recall involves 2,757 cases 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 020-300197, and the affected lot numbers are 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, and 1507012D.

Healthcare facilities and consumers should stop using the affected IV administration sets immediately. Users should check their inventory for the specific product number and lot numbers listed above. If the product is found, it should be quarantined and returned to WalkMed Infusion, LLC in accordance with their field action instructions.

The recalled product

Product
T090-000 90" 20 Drop IV Admin 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.
Manufacturer
WalkMed Infusion, LLC
Category
Medical Device — IV Administration Sets
Hazard
Affected units
2,757

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 (15)

  • Product Number: 020-300197. Lot Number: 1406082
  • 1407122
  • 1408126
  • 1408128
  • 1410078D
  • 1410079D
  • 1410080D
  • 1410081D
  • 1410082D
  • 1411025D
  • 1411026D
  • 1501022D
  • 1501109D
  • 1503083D
  • 1507012D

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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Same hazard · particulate matter

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