Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 — Class II medical device recall Z-0512-2020
Terminated recall by Rocket Medical Plc, reported 2019-12-04, distributed nationwide. A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used
| Recall number | Z-0512-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rocket Medical Plc, Washington, United Kingdom |
| Recall initiated | 2019-08-01 |
| Classified | 2019-11-26 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,081 |
| UPC / GTIN / UDI-DI | 05055270913678 |
| Model numbers | R57405 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0512-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.