Rocket Medical Plc recalls Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Recall date

August 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0512-2020

FDA classification

Class II

Brand / firm

Rocket Medical Plc

Sold / distributed

Nationwide

Why it was recalled

A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

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

What was recalled

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405