Recall Z-2555-2019— Arrow International Inc

Name: FDA recall Z-2555-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-06

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-08-06, terminated 2020-09-29. It names one FDA 510(k) clearance: K011761. Product: 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.. Reason: Products may contain the incorrect banner card within the kit.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Terminated: 2020-09-29
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011761 — MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc.·cleared 2001-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Products may contain the incorrect banner card within the kit

Data sourced from openFDA. This site is unofficial and independent of the FDA.