Recall Z-2911-2016— Arrow International Inc

Name: FDA recall Z-2911-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-07

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2016-07-07, terminated 2017-10-25. It names one FDA 510(k) clearance: K902327. Product: Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.. Reason: Arrow is recalling due to incorrect labeling of products..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Terminated: 2017-10-25
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K902327 — EMBOLECTOMY CATHETERClincal Instruments Corp.·cleared 1991-02-25

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

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

Reason for recall

Arrow is recalling due to incorrect labeling of products.

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