Three-Lumen CVC for use only with Arrow MAC(TM) Two-Lumen Central Venous Access Device

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-2377-2026 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.

• 2 recalls, same reason

  • Terminated Z-1118-2019 FDA Class II ·initiated 10 Jan 2019
  • Terminated Z-1119-2019 FDA Class II ·initiated 10 Jan 2019

  The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

• • Terminated Z-0723-2019 FDA Class II ·initiated 14 Nov 2018

  The lidstock states the incorrect priming volume and flow rates.

• 2 recalls, same reason

  • Terminated Z-2819-2018 FDA Class II ·initiated 10 Jul 2018 ·on shared 510(k) K862056
  • Terminated Z-2818-2018 FDA Class II ·initiated 10 Jul 2018 ·on shared 510(k) K862056

  The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

• • Terminated Z-2336-2018 FDA Class II ·initiated 11 May 2018

  The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.

• 3 recalls, same reason

  • Terminated Z-1982-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1967-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1978-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1332-2018 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.

• 5 recalls, same reason

  • Terminated Z-0650-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0657-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0648-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0654-2018 FDA Class II ·initiated 17 Oct 2017
  • Terminated Z-0652-2018 FDA Class II ·initiated 17 Oct 2017

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

• • Terminated Z-2336-2017 FDA Class II ·initiated 9 May 2017

  The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access

• • Terminated Z-0076-2015 FDA Class II ·initiated 18 Sep 2014

  Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.

• • Terminated Z-0066-2015 FDA Class II ·initiated 6 Aug 2014

  The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.

• • Terminated Z-1965-2013 FDA Class II ·initiated 31 Jul 2013

  Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

• • Terminated Z-0898-2011 FDA Unclassified (pre-2012) ·initiated 9 Nov 2010

  One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.

• • Terminated Z-1653-2009 FDA Unclassified (pre-2012) ·initiated 17 Jun 2009

  The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.

• • Terminated Z-1495-2009 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.

• • Terminated Z-0083-04 FDA Unclassified (pre-2012) ·initiated 16 Sep 2003 ·on shared 510(k) K862056

  wrong product in box

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

Trade Name

Three-Lumen CVC for use only with Arrow MAC(TM) Two-Lumen Central Venous Access Device EUDAMED

Arrow GUDID

Generic Name

Centrally-inserted central venous catheter

Device Name

Central Venous Catheter (CVC) Product

Model / Ref / Catalog

ML-00703, IPN919644

Primary DI / UDI-DI

10801902189452

Basic UDI-DI

08019020000000000000042K8

510(k) Number

K862056 ↗

FDA Product Code

DQY

EMDN Code

C01020203 Central venous multi-lumen (>2) catheters, non-tunneled

GMDN Term

Centrally-inserted central venous catheter

Device Class

Class III EUDAMED

Class II GUDID

Regulation Number

870.1250

Medical Purpose

The Arrow catheter is indicated to permit short-term (< 30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites Central venous pressure monitoring Total parenteral nutrition (TPN) Infusions of fluids, medications, or chemotherapy Frequent blood sampling or receiving blood transfusions/blood products Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400 psi.

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

US-PR-000023158

Category: Central venous catheterization kit, short-term

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