Recall Z-0512-2020— Rocket Medical Plc
Class II · Terminated
Class II FDA medical device recall by Rocket Medical Plc, initiated 2019-08-01, terminated 2021-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Rocket KCH Fetal Bladder Drainage Catheter Model: R57405. 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..
- Recalling firm
- Rocket Medical Plc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-01
- Terminated
- 2021-11-02
- Firm location
- Washington, United Kingdom
Product description
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.