Recall Z-2332-2017— Arrow International Inc

Name: FDA recall Z-2332-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-09

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-05-09, terminated 2018-09-17. It names one FDA 510(k) clearance: K993691. Product: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days. Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Terminated: 2018-09-17
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K993691 — ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.·cleared 2000-03-08

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

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Reason for recall

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

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