WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of T100-000VF 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, which typically corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a potential particulate presence rather than a confirmed severe injury.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action to recall specific lots of T100-000VF IV Sets with Lower Y Site and Free Flow Clip. The recall is being issued due to the potential presence of particulate matter in or on the administration sets. These devices are used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
The affected product is packaged in a Tyvek pouch, with 50 pouches per case. The recall covers 1,857 cases distributed nationwide in the states of Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington. The specific lot numbers involved are 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, and 1508007D.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected IV sets. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- T100-000VF, IV Set with Lower Y Site and 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
- 1,857
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 (12)
- Product Number: 020-300643. Lot Number: 1406089
- 1407017
- 1407018
- 1407019
- 1407506
- 1408132
- 1412071D
- 1412114D
- 1501110D
- 1503055D
- 1506066D
- 1508007D
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 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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