Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Reported: December 4, 2019 Initiated: August 1, 2019 #Z-0512-2020
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.
Details
- Recalling Firm
- Rocket Medical Plc
- Units Affected
- 1081
- Distribution
- Nationwide
- Location
- Washington
Frequently Asked Questions
What product was recalled? ▼
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405. Recalled by Rocket Medical Plc. Units affected: 1081.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0512-2020.
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