Recall Z-1299-2018— Arrow International Inc

Name: FDA recall Z-1299-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-10-24, terminated 2020-04-17. It names one FDA 510(k) clearance: K904021. Product: Pneumothorax Kit. Reason: Product packaging may not be completely sealed..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Terminated: 2020-04-17
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K904021 — PNEUMOTHORAX KIT, MODIFICATIONArrow Intl., Inc.·cleared 1990-10-09

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

Pneumothorax Kit

Reason for recall

Product packaging may not be completely sealed.

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