Merit Medical Recalls Fluid Administration Sets Due to Molding Defect

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.

Category

Medical Device — Fluid Administration Sets

Hazard

• molding-defect

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.

Distribution

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