14 Fr Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+ard Blue Catheter for High Volume Infusions, Pro

• • Ongoing Z-2373-2026 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-1336-2018 FDA Class II ·initiated 22 Dec 2017

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

• • Terminated Z-0658-2018 FDA Class II ·initiated 17 Oct 2017

  These finished good kits may contain the incorrect Springwire Guide (SWG).

• • Terminated Z-2334-2017 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-0639-04 FDA Unclassified (pre-2012) ·initiated 18 Feb 2004

  catheter slips out of the suture wing during use.

510(k) Number

K993933 ↗

FDA Product Code

MPB

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K874105 Active Cleared 24 Nov 1987

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  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

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  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

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• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

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  FDA 510(k) K071998 Active Cleared 26 Sep 2007

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• What types of medical procedures is this catheter specifically designed to support, and why is the 14 French size important for those procedures?

  This catheter is designed to support rapid fluid administration, hemodialysis, apheresis, and hemofiltration by providing dual-lumen access to the central circulation. The 14 French size is optimized for high-volume infusions and dialysis procedures, ensuring efficient blood flow and fluid exchange during these treatments. The larger lumen diameter reduces resistance and improves performance for procedures requiring substantial fluid movement.

• Is this catheter kit single-use or reusable, and what precautions should be taken during storage to maintain sterility?

  This catheter kit is intended for single-use only, as explicitly stated in the manufacturer’s instructions. To maintain sterility, it must be stored within the original sterile packaging until use. Avoid exposing the packaging to moisture, extreme temperatures, or physical damage, as these can compromise sterility and compromise patient safety.

• What features of the Arrowgard Blue catheter help reduce the risk of infection during insertion and use?

  The Arrowgard Blue catheter includes a Blue Flextip, which is designed to enhance insertion safety by reducing trauma to the vessel wall. Additionally, it features an antimicrobial surface protection, which helps minimize catheter-related infections by inhibiting bacterial adhesion and growth on the catheter’s surface.

• What veins are suitable for insertion of this catheter, and how does the Blue Flextip design improve safety?

  This catheter is intended for insertion into the jugular, subclavian, or femoral veins for central venous access. The Blue Flextip design provides a softer, more flexible tip compared to traditional catheters, which reduces the risk of vessel perforation or damage during insertion, improving patient safety and comfort.

• How is the regulatory status of this device determined, and what does the OpenFDA classification (MPB) indicate about its intended use?

  The device holds FDA 510(k) clearance and MDR compliance, confirming it meets regulatory requirements for safety and performance. The OpenFDA classification under MPB (Catheter, Hemodialysis, Non-Implanted) under regulation 876.5540 categorizes it as a non-implanted hemodialysis catheter, meaning it is not intended for long-term internal placement but rather for temporary central venous access during procedures like dialysis or high-volume infusions.