Device product
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.
Z-0285-2020
Product summary
- Event
- Event 83886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0285-2020
Official wording
Reason: A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
Code information: REDR0440
Distribution pattern: Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
Derived failure modes
-
Unknown
A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.