WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion, LLC is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on 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 contamination hazard (particulate matter) where no specific injuries or illnesses are 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 T090-022V 90-inch 20 Drop IV Administration Sets. These needle-free Y-site sets with 0.22 filters are packaged in Tyvek pouches and are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
The recall is being issued due to the potential presence of particulate matter in or on the administration sets. The affected product is identified by Product Number 020-300206 and includes Lot Numbers 1406087, 1407505, 1409132D, 1409133D, 1412060D, and 1503090D. A total of 679 cases were distributed nationwide in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products immediately. The source text does not provide specific instructions for disposal or return, but users should contact WalkMed Infusion, LLC for further guidance.
The recalled product
- Product
- T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. 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
- 679
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: 020-300206. Lot Number: 1406087
- 1407505
- 1409132D
- 1409133D
- 1412060D
- 1503090D
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
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- 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
- HighWalkMed Recalls IV Administration Sets Due to Particulate Presence
FDA (Devices) · 2016-07-27
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