Arrow International Inc recalls 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Produc…

Recall date

August 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2555-2019

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Products may contain the incorrect banner card within the kit

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard¿ technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard¿ antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.