FDA recall Z-0512-2020

Product

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-08-01

Report date

2019-12-04

Termination date

2021-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Washington, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2020