Two-Lumen Central Venous Access Kit with 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.

• 2 recalls, same reason

  • Terminated Z-0352-2023 FDA Class I ·initiated 27 Oct 2022 ·on shared 510(k) K002507
  • Terminated Z-0351-2023 FDA Class I ·initiated 27 Oct 2022 ·on shared 510(k) K002507

  There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

• • Terminated Z-1323-2018 FDA Class II ·initiated 22 Dec 2017 ·on shared 510(k) K002507

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

• • Terminated Z-2335-2017 FDA Class II ·initiated 9 May 2017 ·on shared 510(k) K002507

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

• 53 recalls, same reason

  • Terminated Z-2288-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2287-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2298-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2304-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2290-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2292-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2269-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2262-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2302-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2293-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2301-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2281-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2256-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2272-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2268-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2275-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2265-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2277-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2289-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2274-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2282-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2276-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2300-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2299-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2284-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2258-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2283-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2296-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2291-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2270-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2259-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2254-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2286-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2257-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2273-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2278-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2295-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2260-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2279-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2297-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2266-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2255-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2285-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2264-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2267-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2263-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2305-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2303-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2261-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2280-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2253-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2271-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2294-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507

  Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

• 3 recalls, same reason

  • Terminated Z-2306-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2308-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507
  • Terminated Z-2307-2017 FDA Class II ·initiated 20 Mar 2017 ·on shared 510(k) K002507

  The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard Blue antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue antimicrobial surface in decreasing catheterrelated infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

• • Terminated Z-2825-2015 FDA Class II ·initiated 27 Aug 2015 ·on shared 510(k) K002507

  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-2488-2010 FDA Unclassified (pre-2012) ·initiated 29 Jul 2010

  Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

• • Terminated Z-1496-2009 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.

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

510(k) Number

K002507 ↗

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

  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. →