Medical device recalls Moderate risk

Merit Medical Systems, Inc. recalls ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from…

Recall date
June 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2352-2015
FDA classification
Class II
Brand / firm
Merit Medical Systems, Inc.
Sold / distributed
Nationwide Distribution including the Virgin Islands.

Why it was recalled

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

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