Device evidence

device-recall:cfres:162067

ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

Official recall number

Z-1002-2018

Evidence summary

Product code: FOZ
Recall status: Terminated
Event initiated: November 27, 2017
Root cause: Error in labeling
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1002-2018