Z-1152-2018 Class II Terminated
FDA device recall Z-1152-2018 was initiated by Arrow International Inc on December 21, 2017 and is designated Class II. Reason for recall: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information. The recall status is terminated (terminated April 20, 2020). Affected quantity: 420.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- December 21, 2017
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420
Product 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.
Reason for Recall
Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
Distribution Pattern
United States in the state of FL.
Code Information
Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781