The Recall Desk
ModerateFDA (Devices)·Z-0512-2020·Announced 2019-12-04

Rocket KCH Fetal Bladder Drainage Catheter Recalled for Kinking and Off-Label Use

Rocket Medical Plc is recalling 1,081 KCH Fetal Bladder Drainage Catheters due to reported kinking and off-label use for pleural drainage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazards involve a functional defect (kinking) and off-label use, which are significant but do not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).

Plain-English summary

Rocket Medical Plc is recalling 1,081 units of the Rocket KCH Fetal Bladder Drainage Catheter, Model R57405. The recall is nationwide and includes all lots under UDI 05055270913678.

The recall was initiated after a complaint was received regarding kinking of the device prior to use. The source notes that if a device is kinked, it cannot be used. Additionally, the company became aware that the device had been used for pleural drainage, which is not included in the device's indications.

Healthcare providers and consumers should stop using the affected devices and contact Rocket Medical Plc for further instructions.

The recalled product

Product
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Manufacturer
Rocket Medical Plc
Category
Medical Device — Catheter
Hazard
Affected units
1,081

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots (UDI): 05055270913678

Distribution

Distributed nationwide across the United States.

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