Reported Dec 4, 2019 · Terminated

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Rocket Medical PLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rocket Medical Plc · Industrial Estate Sedling Road Wear Indu · Washington · N/A

Is this the product you have?

  • Rocket KCH
  • Fetal Bladder Drainage Catheter ModelR57405
Lot codes and dates
  • All lots (UDI)05055270913678
Amount recalled
1081

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 2, 2021 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.