WalkMed Infusion Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling T100-000F IV 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 a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action for multiple Triton Administration Sets, specifically the T100-000F 100-inch IV Set with Free Flow Clip. 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 a Tyvek pouch, with 50 pouches per case. The specific product number is 020-300642. The recall covers 1,323 cases across the following lot numbers: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, and 1508008D.
These products were distributed nationwide in the United States to the states of Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington. The IV sets are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
The recalled product
- Product
- T100-000F, 100" IV Set with 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 — Infusion Sets
- Hazard
- Affected units
- 1,323
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 (9)
- Product Number: 020-300642. Lot Number: 1406088
- 1406163
- 1406164
- 1406165
- 1409041D
- 1409134D
- 1410165D
- 1506065D
- 1508008D
Distribution
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
See all →- HighWalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereAmerican Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereFDA Recalls Nicardipine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Multrys Trace Elements Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26