WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of IV sets with 0.22 micron filters 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 risk of harm (particulate matter) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action to recall specific lots of T095-022 IV Sets with 0.22 Micron Filters. 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 Tyvek pouches, with 50 pouches per case. The specific product number is 020-300576, and the affected lot numbers are 1407016, 1410164D, 1411070D, 1501024D, 1503091D, and 1506091D. A total of 304 cases were distributed nationwide to the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
These IV sets are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. Healthcare providers and consumers should check their inventory for the specific lot numbers listed above and stop using the affected products if found.
The recalled product
- Product
- T095-022, IV Set with 0.22 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
- Hazard
- Affected units
- 304
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: 020-300576. Lot Number: 1407016
- 1410164D
- 1411070D
- 1501024D
- 1503091D
- 1506091D
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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