Rocket Medical Plc: Medical Device Recall in 2019 - (Recall #: Z-0512-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Product Classification:

Class II

Date Initiated: August 1, 2019

Date Posted: December 4, 2019

Recall Number: Z-0512-2020

Event ID: 83587

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.

Status: Terminated

Product Quantity: 1081

Code Information:

All lots (UDI): 05055270913678

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated