WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter on or in the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 particulate hazard where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products without reported injury.
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 T095-120 IV Set with a 1.2 Micron Filter, packaged in a Tyvek pouch with 50 pouches per case. These devices are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. The specific product number is 020-300577 and the lot number is 1407025.
A total of 58 cases were distributed nationwide 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 consumers should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- T095-120 IV Set with 1.2 Micron Filter. 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
- Affected units
- 58
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 (1)
- Product Number: 020-300577. Lot Number: 1407025
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
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FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Sets Due to Potential Particulate Presence
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- 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
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