Recall Z-1005-2015— Arrow International Inc

Name: FDA recall Z-1005-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-16

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2014-12-16, terminated 2015-08-10. It names one FDA 510(k) clearance: K071538. Product: Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.. Reason: the Instructions for Use (IFU) were inadvertently removed from the kit..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Terminated: 2015-08-10
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K071538 — ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERArrow International, Inc.·cleared 2007-08-30

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

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Reason for recall

the Instructions for Use (IFU) were inadvertently removed from the kit.

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