Z-0285-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- September 16, 2019
- Termination Date
- June 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
Reason for Recall
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
Distribution Pattern
Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
Code Information
REDR0440