Z-0512-2020 Class II Terminated
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