Rocket KCH Fetal Bladder Drainage Catheter recallZ-0512-2020 · Rocket Medical Plc · initiated Aug 1, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Rocket Medical Plc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
Rocket Medical issued Urgent Field Safety Notice (FSN) dated July 30, 2019 advising of problem, action taken: update to IFU-Do NOT pull the tip of the catheter in an attempt to straighten it as this will induce twisting of the material and cause the catheter to kink. In addition added :This product is contraindicated for pleural drainage. Communicate this FSN to Hospital Supply Departments, Medical Device Safety Officers and those working within fetal medicine within your facility. For any devices that have been transferred to other organization(s), please ensure that details of these devices are returned to Rocket Medical and that a copy of the FSN is provided to the organization(s) to which the device has been transferred. Complete, scan and return response form, or email your responses, as soon as possible but before August 31st to [email protected].
Recall details
- Recall number
- Z-0512-2020
- Status
- Terminated
- Initiated by the company
- Aug 1, 2019
- Recalling firm
- Rocket Medical Plc
- Quantity
- 1081
- Product code
- MPR
- Distribution
- Nationwide
Product description
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Code information (models, lots, serial numbers)
All lots (UDI): 05055270913678
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Rocket R57405Rocket Medical PLC1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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