Recall Z-0512-2020 ยท MPR Stent, Bladder, Fetal
Rocket Medical Plc
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
| Date | Aug 1, 2019 |
| 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. |
| 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 |
| Quantity | 1081 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.