Arrowg +ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter

• • Ongoing Z-2376-2026 FDA Class I ·initiated 21 Apr 2026 ·on shared 510(k) K993691

  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-1106-2021 FDA Class II ·initiated 6 Jan 2021

  The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction

• • Terminated Z-0192-2020 FDA Class II ·initiated 18 Jul 2019

  Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length

• • Terminated Z-0468-2019 FDA Class II ·initiated 21 Sep 2018

  The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .

• • Terminated Z-0282-2019 FDA Class II ·initiated 30 Aug 2018

  The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading to a minor delay while a replacement is located. In the unlikely event that the product lidstock is not checked prior to use, there is potential for use of expired product, and product functionality/or sterility cannot be guaranteed.

• 5 recalls, same reason

  • Terminated Z-2002-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2003-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2004-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2005-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2001-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1335-2018 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-1152-2018 FDA Class II ·initiated 21 Dec 2017

  Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

• • Terminated Z-0656-2018 FDA Class II ·initiated 17 Oct 2017

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

• • Terminated Z-2332-2017 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-1507-2014 FDA Class II ·initiated 17 Jul 2013

  Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM

• • Terminated Z-2493-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

• 4 recalls, same reason

  • Terminated Z-0788-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0786-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0787-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0785-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009

  Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

• • Terminated Z-1498-2009 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-0059-05 FDA Unclassified (pre-2012) ·initiated 27 Sep 2004

  Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK

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

510(k) Number

K993691 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

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  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

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• 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

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

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