Class II — Rocket Medical Plc
| Recalling firm | Rocket Medical Plc |
|---|---|
| Registered facility | ROCKET MEDICAL PLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 |
| Quantity | 1081 |
| Distribution | Nationwide |
| Initiated | 2019-08-01 |
| Classified | 2019-11-26 |
| Terminated | 2021-11-02 |
| Recall number | Z-0512-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Rocket Medical Plc (Z-0512-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83587/
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