The Recall Desk
ModerateFDA (Devices)·Z-2225-2016·Announced 2016-07-27

WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

WalkMed Infusion is voluntarily recalling specific IV administration sets due to the potential presence of particulate matter in or on the devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary field action for a potential contamination issue (particulate matter) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

WalkMed Infusion, LLC is conducting a voluntary field action for 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 T090-000W 90" 20 Drop IV Admin Set with 2 Needlefree Y-Sites and a Back Check Valve. These sets are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. The recall covers 7,529 cases, with 50 pouches per case. The products were distributed nationwide in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

Healthcare providers and consumers should check their inventory for the specific product number 020-300204 and the listed lot numbers. If the product is found, it should be removed from use and returned to WalkMed Infusion, LLC in accordance with their instructions.

The recalled product

Product
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. 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
7,529

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 (20)

  • Product Number: 020-300204. Lot Number: 1406006
  • 1406008
  • 1406170
  • 1406171
  • 1406172
  • 1406173
  • 1406174
  • 1407125
  • 1407126
  • 1407127
  • 1407128
  • 1407129
  • 1408076
  • 1408077
  • 1409038D
  • 1409039D
  • 1409040D
  • 1410074D
  • 1410075D
  • 1410076D

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 →