Recall Z-1165-2018— Arrow International Inc

Name: FDA recall Z-1165-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-14

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-11-14, terminated 2019-07-15. It names one FDA 510(k) clearance: K071538. Product: Pressure Injectable Multi- Lumen CVC Kit. Reason: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-14
Terminated: 2019-07-15
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

Pressure Injectable Multi- Lumen CVC Kit

Reason for recall

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

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