MAC(TM) Two-Lumen Central Venous Access Set with Integral Hemostasis Valve for use with 7 - 7.5 Fr. Catheters

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-2385-2026 FDA Class I ·initiated 21 Apr 2026 ·on shared 510(k) K002507

  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
  • Terminated Z-0351-2023 FDA Class I ·initiated 27 Oct 2022

  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

  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

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

  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
  • Terminated Z-2308-2017 FDA Class II ·initiated 20 Mar 2017
  • Terminated Z-2307-2017 FDA Class II ·initiated 20 Mar 2017

  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

  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 ·on shared 510(k) K002507

  Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

• • Terminated Z-1496-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2009 ·on shared 510(k) K002507

  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.

Trade Name

MAC(TM) Two-Lumen Central Venous Access Set with Integral Hemostasis Valve for use with 7 - 7.5 Fr. Catheters EUDAMED

Arrow GUDID

Generic Name

Vascular catheter introduction set, nonimplantable

Device Name

Multi-Lumen Access Catheter (MAC) & Percutaneous Sheath Introducer (PSI) Product

Model / Ref / Catalog

SI-11242, IPNB00348

Primary DI / UDI-DI

10801902200010, 10801902226195

Basic UDI-DI

08019020000000000000103K3, 08019020000000000000121K5

510(k) Number

K002507 ↗

FDA Product Code

FOZ

EMDN Code

C0502 Cardiovascular introducer sheaths, valved

GMDN Term

Vascular catheter introduction set, nonimplantable

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

880.5200

Market of Registration

Ireland

Medical Purpose

The Arrow Multi-Lumen Central Venous Access Device permits venous access for procedures requiring large volume fluid infusion or catheter introduction to the central circulation

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

US-MF-000024256

Authorised representative

Teleflex Medical IE-AR-000015869

Category: Vascular catheter introduction set, nonimplantable

• Pressure Injectable One-Lumen PICC

  Class III

  CE/MDR

• Three-Lumen CVC

  Class III

  CE/MDR

• Arrowg+ard Blue(R) Five-Lumen CVC

  Class III

  CE/MDR

• Two-Lumen CVC

  Class III

  CE/MDR

• Arterial Catheterization Set

  Class IIb

  CE/MDR

• Arrowg+ard Blue(R) Two-Lumen CVC

  Class III

  CE/MDR

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