Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port

• • Ongoing Z-2385-2026 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-2555-2019 FDA Class II ·initiated 6 Aug 2019

  Products may contain the incorrect banner card within the kit

• • Terminated Z-1983-2018 FDA Class II ·initiated 11 Apr 2018 ·on shared 510(k) K011761

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1324-2018 FDA Class II ·initiated 22 Dec 2017 ·on shared 510(k) K011761

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

• 2 recalls, same reason

  • Terminated Z-1000-2018 FDA Class II ·initiated 27 Nov 2017 ·on shared 510(k) K011761
  • Terminated Z-1002-2018 FDA Class II ·initiated 27 Nov 2017 ·on shared 510(k) K011761

  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-2333-2017 FDA Class II ·initiated 9 May 2017 ·on shared 510(k) K011761

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

• • Terminated Z-2825-2015 FDA Class II ·initiated 27 Aug 2015 ·on shared 510(k) K011761

  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-0066-2015 FDA Class II ·initiated 6 Aug 2014 ·on shared 510(k) K011761

  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-0783-2010 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.

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

510(k) Number

K011761 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

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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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  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

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  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. →