Z-0192-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- July 18, 2019
- Termination Date
- November 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 745 eaches
Product Description
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - 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.
Reason for Recall
Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: 13F18L0759