Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection

• • Ongoing Z-2395-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• • Terminated Z-2825-2015 FDA Class II ·initiated 27 Aug 2015 ·on shared 510(k) K003006

  Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K003006 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 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

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• 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

See all devices from Arrow Intl., Inc. →