Merit Medical Recalls Fluid Administration Sets Due to Molding Defect
Merit Medical Systems is voluntarily recalling 107,341 Fluid Administration Sets due to a molding defect in the drip chamber.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action for a molding defect with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for its Custom Fluid Management Sets. The recall involves 107,341 devices that were distributed nationwide. These sterile, prescription-only sets are used to transfer contrast media and saline from a container to a patient's vascular system.
The field action is being taken due to a molding defect in the drip chamber of the affected devices. The source text does not specify the exact nature of the defect or any reported adverse health consequences.
Healthcare facilities and consumers should identify affected devices by checking the part numbers listed in the official recall notice. The recall number is Z-0649-2017.
The recalled product
- Product
- Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 107,341
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 (20)
- Part Number: 701610001
- K08-02053A
- K08-02111A
- K-08-2192A
- K08-02385
- K08-02385P
- K08-02649
- K08-02690
- K08-02930a
- K08-03044
- K08T-02829
- K09-00807AD
- K09-01467AC
- K09-01467AD
- K09-01732N
- K09-02334N
- K09-02608A
- K09-03491HP
- K09-03586AC
- K09-03743L
Distribution
Distributed nationwide across the United States.
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