FDA Device recall Z-0512-2020
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 by Rocket Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0512-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-01 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Rocket Medical |
| Distribution | US |
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.
Identifiers
| code_info | All lots (UDI): 05055270913678 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0512-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.