Arrow IPN921089

• EUDAMED Basic UDI-DI 08019020000000000000039KK registered 1 Jun 2026 Active
• FDA 510(k) K011761 decided 31 Oct 2001 Active
• FDA GUDID UDI-DI 10801902199970 listed 12 Jun 2023 Listed

• • 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.

1. 27 Aug 2015 Recall initiated FDA recalls Z-2825-2015
2. 9 May 2017 Recall initiated FDA recalls Z-2333-2017
3. 27 Nov 2017 Recall initiated FDA recalls Z-1000-2018
4. 27 Nov 2017 Recall initiated FDA recalls Z-1002-2018
5. 22 Dec 2017 Recall initiated FDA recalls Z-1324-2018
6. 11 Apr 2018 Recall initiated FDA recalls Z-1983-2018
7. 6 Aug 2019 Recall initiated FDA recalls Z-2555-2019
8. 12 Jun 2023 Listed FDA GUDID 10801902199970
9. 21 Apr 2026 Recall initiated FDA recalls Z-2385-2026
10. 1 Jun 2026 Registered EUDAMED 08019020000000000000039KK

3 earlier events are in the sections above.

Trade name

Arrowg+ard Blue(R) 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

ARROWg+ard Blue Percutaneous Sheath Introducers/MACs

Model / Ref / Catalog

SI-21142, IPN921089

Primary DI / UDI-DI

10801902199970

Basic UDI-DI

08019020000000000000039KK

510(k) Number

K011761 ↗

FDA product code

DYB

EMDN code

C0502 Cardiovascular introducer sheaths, valved

GMDN term

Vascular catheter introduction set, nonimplantable

Device class

Class III EUDAMED

Class II GUDID

Regulation number

870.1340

EU registration type

Standard device

EU market of registration

Ireland

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Vascular catheter introduction set, nonimplantable

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

• One-Piece Catheter Introducer 496156 by Argon Medical Devices, Inc.
• SSPC Delivery Catheter 9184 by CenterPoint Systems LLC
• SSPC Delivery Catheter 9181 by CenterPoint Systems LLC
• One-Piece 496152 by Argon Medical Devices, Inc.
• IVA introducers sheat IVA3F by Balt extrusion SAS
• PREFACE 301803M by Biosense Webster Inc
• IVA introducers sheat IVA3F50 by Balt extrusion SAS
• Guiding Sheath (GSQ) GSQ120A5 by Q3 Medical Germany GmbH
• Check-Flo G08686 RCFW-10.0-38-30-RB by COOK INCORPORATED
• Check-Flo G09256 RCFW-11.0-38-30-RB by COOK INCORPORATED

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →