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Rocket Medical Plc recalls Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Recalled December 4, 2019 · FDA recall Z-0512-2020 · Rocket Medical
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. · FDA Class II
Units
1081
Sold at
Nationwide
Description
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.
Product
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Manufacturer(s)
Rocket Medical Plc
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →