PICC

• • Ongoing Z-2378-2026 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) K042126

  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.

• • Terminated Z-2462-2015 FDA Class II ·initiated 30 Jul 2015

  the catheter peel-away component hub tabs may prematurely detach. One injury reported.

• • Terminated Z-1503-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2009

  Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

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

510(k) Number

K042126 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESU

• 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. →

• What is the intended use of the Arrow Intl. PICC?

  The PICC is an intravascular, therapeutic device designed to provide long-term vascular access. It is specifically indicated for use in patients requiring therapy for periods exceeding 30 days.

• How is this device supplied to clinicians?

  The device is supplied as a kit, which includes the necessary components for the peripherally inserted central venous catheter procedure.

• What material is used to manufacture the PICC?

  The catheter is manufactured using flexible polyurethane, a material selected for its physical properties to facilitate long-term placement within the vascular system.

• What is the regulatory status of this device?

  This device is subject to FDA 510(k) authorization under regulation number 880.5970, which governs the classification and requirements for peripherally inserted central venous catheters.