CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report

Rocket KCH Fetal Bladder Drainage Catheter recalled by Rocket Medical

Rocket Medical is recalling Rocket KCH Fetal Bladder Drainage Catheter, distributed nationwide in the US. The recall was initiated on 1 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots (UDI): 05055270913678

Quantity recalled1081

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0512-2020
FDA event ID: 83587
Recalling firm: Rocket Medical, Washington
Classification: Class II
Status: Terminated
Recall initiated: 1 Aug 2019
FDA classified: 26 Nov 2019
Reported: 4 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

1 Aug 2019	Recall initiated by company
26 Nov 2019	Classified by FDA	+117 days
4 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Where it was distributed

Nationwide

Questions about this recall

Is Rocket KCH Fetal Bladder Drainage Catheter recalled?

Yes. Rocket Medical recalled Rocket KCH Fetal Bladder Drainage Catheter on 1 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0512-2020.

Why was it recalled?

Which lots are affected?

All lots (UDI): 05055270913678

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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