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 potential contamination hazard (particulate matter) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action to recall specific lots of Triton IV administration sets. The recall is being issued because of the potential presence of particulate matter in or on the administration sets.
The affected product is the T100-022WF IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP 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 covers 1,147 cases, with 50 pouches per case. The specific lot numbers involved are 1406166, 1406167, 1406168, 1406169, 1407507, and 1408134.
The affected products were distributed nationwide in the United States, specifically in the states of Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected sets.
The recalled product
- Product
- T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP 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
- Affected units
- 1,147
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 (6)
- Product Number: 020-300828. Lot Number: 1406166
- 1406167
- 1406168
- 1406169
- 1407507
- 1408134
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
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- HighWalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
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