Recall Z-1233-2015— Arrow International Inc

Name: FDA recall Z-1233-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-05

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2015-02-05, terminated 2016-10-26. It names one FDA 510(k) clearance: K021462. Product: ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle. Reason: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Terminated: 2016-10-26
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K021462 — ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840Arrow Intl., Inc.·cleared 2002-06-06

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

ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

Reason for recall

Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

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