Arrow Picc-Peripherally Inserted Central Catheter

• • Terminated Z-2021-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1228-2017 FDA Class II ·initiated 11 Jan 2017

  There have been complaints for peel away sheaths flaring

• 2 recalls, same reason

  • Terminated Z-0551-05 FDA Unclassified (pre-2012) ·initiated 21 Sep 2004
  • Terminated Z-0552-05 FDA Unclassified (pre-2012) ·initiated 21 Sep 2004

  Product was mislabeled for lumen configuration, flow rates, and priming volume.

510(k) Number

K930129 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SEKD

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

• 8 Fr.-40cc Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.SHEATH)

  Class II

  FDA 510(k) K960713 Active Cleared 15 May 1996

See all devices from Arrow Intl., Inc. →