The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2352-2015·Announced 2015-08-19

Merit Medical Recalls ReSolve Locking Drainage Catheters Due to Labeling Discrepancy

Merit Medical Systems is voluntarily recalling 950 ReSolve Locking Drainage Catheters because the unit labeling may not match the actual device in the package.

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 classified as FDA Class II and involves a labeling discrepancy. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.

Plain-English summary

Merit Medical Systems, Inc. is voluntarily recalling 950 units of ReSolve Locking Drainage Catheters. These medical devices are intended for the percutaneous drainage of fluids from body cavities.

The recall is being conducted due to a potential discrepancy between the unit labeling of the catheters and the actual device contained in the package. This means the label on the packaging may not accurately describe the specific catheter inside.

The affected products were distributed nationwide, including the Virgin Islands. Specific lot numbers involved in this recall include E796578, E796579, MR792035, MR786325, MR797946, MR791206, MR791212, MR786923, E796605, MR786311, MR791660, E796647, MR795466, MR786301, E796629, E796631, E796636, E796637, MR786306, MR786320, MR786318, and MR786319. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using any affected units.

The recalled product

Product
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Drainage Catheters
Hazard
Affected units
950

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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