Z-0512-2020 Class II Terminated
FDA device recall Z-0512-2020 was initiated by Rocket Medical Plc on August 1, 2019 and is designated Class II. 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… The recall status is terminated (terminated November 2, 2021). Affected quantity: 1081.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- August 1, 2019
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1081
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.
Distribution Pattern
Nationwide
Code Information
All lots (UDI): 05055270913678