FDA-Device2019-12-04Class II
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Rocket Medical Plc
Hazard
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.
Sold states
Nationwide
Affected count
1081
Manufactured in
Industrial Estate Sedling Road Wear Indu, Tyne & Wear, Washington, United Kingdom
Products
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2020Don't want to check this manually?
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