Antimicrobial Multi-Lumen Central Venous Catheter

• • Ongoing Z-2376-2026 FDA Class I ·initiated 21 Apr 2026 ·on shared 510(k) K900263

  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-0053-2020 FDA Class II ·initiated 17 May 2019

  Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

• • Terminated Z-2886-2018 FDA Class II ·initiated 3 Jul 2018

  One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.

• 2 recalls, same reason

  • Terminated Z-1984-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-1985-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1333-2018 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-1001-2018 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-2337-2017 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-1830-2012 FDA Class I ·initiated 3 May 2012

  Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.

• • Terminated Z-2496-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

• • Terminated Z-1499-2009 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-0082-04 FDA Unclassified (pre-2012) ·initiated 16 Sep 2003 ·on shared 510(k) K900263

  wrong product in box

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

510(k) Number

K900263 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

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

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  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. →