Z-0512-2020Class II

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Name: Z-0512-2020 Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Creator: Rocket Medical Plc
Published: 2019-08-01
License: https://open.fda.gov/license/

Rocket Medical / initiated 2019-08-01 / Terminated / root cause: labeling and UDI

FDA source

Rocket Medical Plc began a recall of Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 on 2019-08-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0512-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-01
Posted: 2019-11-26
Terminated: 2021-11-02
Recalling firm: Rocket Medical
Product: Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Product code: MPR Stent, Bladder, Fetal
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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].
Quantity in commerce: 1081
Distribution: Nationwide
Product codes and lots: All lots (UDI): 05055270913678

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0512-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0512-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-26

Product code MPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)