Z-1879-2017 Class II Terminated
FDA device recall Z-1879-2017 was initiated by Arrow International Inc on March 17, 2017 and is designated Class II. Reason for recall: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. The recall status is terminated (terminated March 24, 2020). Affected quantity: 310 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- March 17, 2017
- Termination Date
- March 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 310 units
Product 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
Reason for Recall
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Distribution Pattern
US Distribution to NJ, IL, and PA
Code Information
Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199