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Recall Observatory FDA recall evidence

Device product

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Z-0512-2020

August 01, 2019

Class II

Product summary

Firm
Rocket Medical Plc
Event
Event 83587
Status
Terminated
Classification
Class II
Quantity
1081
Official record key
device-enforcement:Z-0512-2020

Official wording

Reason: 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.

Code information: All lots (UDI): 05055270913678

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.