Device product
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter 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 ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.
Z-1152-2018
Product summary
- Event
- Event 79528
- Status
- Terminated
- Classification
- Class II
- Quantity
- 420
- Official record key
device-enforcement:Z-1152-2018
Official wording
Reason: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
Code information: Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781
Distribution pattern: United States in the state of FL.
Derived failure modes
-
Unknown
Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.