FDA Medical Device Recalls (openFDA)
Rocket Medical Plc: Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
- Recall number
- Z-0512-2020
- Recalling firm
- Rocket Medical Plc
- Product
- Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
- Status
- Terminated
- Initiated
- 2019-08-01
- Posted
- not on file
- Terminated
- 2021-11-02
- 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.
- 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 cust-occ110@rocketmedical.com.
- Quantity
- 1081
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots (UDI): 05055270913678
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MPR
- Firm FEI
- 3002808026
- Firm city
- Washington
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28