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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