Recall Z-1000-2018— Arrow International Inc

Name: FDA recall Z-1000-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-27

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-11-27, terminated 2020-09-22. It names one FDA 510(k) clearance: K011761. Product: ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.. Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Terminated: 2020-09-22
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

ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

Reason for recall

Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

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