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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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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