Recall Z-1324-2018— Arrow International Inc

Name: FDA recall Z-1324-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-12-22, terminated 2020-05-27. It names one FDA 510(k) clearance: K011761. Product: (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A. Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Terminated: 2020-05-27
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

(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

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