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
Enforcement
- Recall Number
- Z-1879-2017
- Event ID
- 76935
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 3, 2017
- Initiation Date
- March 17, 2017
- Classification Date
- April 26, 2017
- Termination Date
- March 24, 2020
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
Description
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
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199
US Distribution to NJ, IL, and PA
310 units