Device product
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.
Z-2550-2020
Product summary
- Event
- Event 85808
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1710
- Official record key
device-enforcement:Z-2550-2020
Official wording
Reason: Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
Code information: Lot number 269939, 270552, 270874, and 272261.
Distribution pattern: US Nationwide distribution including in the state of NY.
Derived failure modes
-
Labeling or packaging
mislabeled