Recall Z-1830-2012— Arrow International Inc

Name: FDA recall Z-1830-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-03

Class I · Terminated

Class I FDA medical device recall by Arrow International Inc, initiated 2012-05-03, terminated 2013-03-22. It names one FDA 510(k) clearance: K900263. Product: Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.. Reason: Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status..

Recalling firm: Arrow International Inc
Classification: Class I
Status: Terminated
Initiated: 2012-05-03
Terminated: 2013-03-22
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K900263 — ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.·cleared 1990-07-24

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 Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.

Reason for recall

Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.

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