Rocket KCH Fetal Bladder Drainage Catheter recall
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
Why was Rocket KCH Fetal Bladder Drainage Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots (UDI): 05055270913678
- Product
- Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
- Recalling firm
- Rocket Medical Plc
- Quantity
- 1081
- Distribution
- Nationwide
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)