Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • 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.

• 4 recalls, same reason

  • Terminated Z-1822-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1820-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1811-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1819-2019 FDA Class II ·initiated 23 Apr 2019

  Lidstock states the incorrect expiration date for the product

• • Terminated Z-1327-2018 FDA Class II ·initiated 22 Dec 2017 ·on shared 510(k) K112896

  Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

• • Terminated Z-0996-2018 FDA Class II ·initiated 27 Nov 2017

  Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

• • Terminated Z-2698-2017 FDA Class II ·initiated 12 Jun 2017

  Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

• • Terminated Z-2331-2017 FDA Class II ·initiated 9 May 2017

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

• • Terminated Z-1705-2017 FDA Class II ·initiated 3 Mar 2017

  Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

• • Terminated Z-0207-2016 FDA Class II ·initiated 16 Oct 2015

  Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

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

Trade Name

Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC EUDAMED

Arrow GUDID

Generic Name

Peripherally-inserted central venous catheter

Device Name

Arrowg+ard Blue Advance (AGBA) Peripherally Inserted Central Catheter (PICC) Product

Model / Ref / Catalog

IDLX-45552-HPK, IPN930593

Primary DI / UDI-DI

10801902222043

Basic UDI-DI

08019020000000000000050K7

510(k) Number

K112896 ↗

FDA Product Code

LJS

EMDN Code

C01020102 Central i.v. multi-lumen catheters, peripheral access

GMDN Term

Peripherally-inserted central venous catheter

Device Class

Class III EUDAMED

Class II GUDID

Regulation Number

880.5970

Medical Purpose

The Pressure Injectable PICC is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Pressure Injectable PICC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate ranges from 4 mL/sec to 6 mL/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection. Arrowg+ard Blue Advance Protection treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods, and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Safe

EUDAMED SRN

US-PR-000023158

• Pressure Injectable One-Lumen PICC

  Class III

  CE/MDR

• Three-Lumen CVC

  Class III

  CE/MDR

• Arrowg+ard Blue(R) Five-Lumen CVC

  Class III

  CE/MDR

• Two-Lumen CVC

  Class III

  CE/MDR

• Arterial Catheterization Set

  Class IIb

  CE/MDR

• Arrowg+ard Blue(R) Two-Lumen CVC

  Class III

  CE/MDR

See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →