CareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks
CareFusion is recalling 12,850 MaxGuard Extension Sets because the 0.2 micron filter may leak. These medical devices are used to administer fluids to patients.
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 functional defect (filter leaks) that poses a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling 12,850 units of the MaxGuard Extension Set, including models ME2064, MP9009C, MP9209, and MP9254C. The recall is due to reports of leaks occurring with the 0.2 micron filter component. The affected lots are 15045419, 15075822, 15086644, 16036290, 16056204, 16075270, 15086404, 16067461, 16046571, and 16045810.
These extension sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into an artery or vein. The sets may incorporate components designed to prevent accidental needle sticks. The products were distributed nationwide.
Healthcare facilities and consumers should check their inventory for the specific model numbers and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may…
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 12,850
Distribution
Distributed nationwide across the United States.
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