Device product
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Z-1879-2017
Product summary
- Event
- Event 76935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310 units
- Official record key
device-enforcement:Z-1879-2017
Official wording
Reason: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Code information: Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199
Distribution pattern: US Distribution to NJ, IL, and PA
Derived failure modes
-
Unknown
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.