Recall Z-3197-2018— Arrow International Inc

Name: FDA recall Z-3197-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-30

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-07-30, terminated 2019-07-11. It names one FDA 510(k) clearance: K945229. Product: ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording. Reason: Products are labeled with an incorrect expiration date.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-30
Terminated: 2019-07-11
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K945229 — ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSArrow Intl., Inc.·cleared 1995-08-08

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¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

Reason for recall

Products are labeled with an incorrect expiration date

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