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.
Enforcement
- Recall Number
- Z-1152-2018
- Event ID
- 79528
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 28, 2018
- Initiation Date
- December 21, 2017
- Classification Date
- March 21, 2018
- Termination Date
- April 20, 2020
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
Description
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.
Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781
United States in the state of FL.
420