Device product
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
Z-2337-2017
Product summary
- Event
- Event 77232
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,485 units distributed in U.S., 4,371 units distributed internationally
- Official record key
device-enforcement:Z-2337-2017
Official wording
Reason: 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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Code information: Material number: CDC-24301-1A, CDC-24306-1A Device Listing D025398
Distribution pattern: Worldwide Distribution - US (nationwide) and Canada
Derived failure modes
-
Unknown
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 components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access