WalkMed Infusion Recalls Spike Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling 12-inch Microbore Spike 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) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action for multiple Triton Administration Sets, specifically the 12-inch Microbore SPM-12 Spike Sets. The recall is being issued due to the potential presence of particulate matter in or on the administration sets. These products 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 specific product number is 020-204840 and the lot number is 1504031D. A total of 37 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 facilities should stop using the affected Spike Sets immediately. Consumers and medical staff should check their inventory for the specific product number and lot number listed above. If the product is found, it should be returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Spike Set, 12" Microbore SPM-12. 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
- 37
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: 020-204840. Lot Number: 1504031D
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.
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