Arrow IPN029625

• FDA 510(k) K993933 decided 14 Sep 2000 Active
• FDA GUDID UDI-DI 10801902143713 listed 31 Oct 2018 Listed

• • Ongoing Z-2373-2026 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-1336-2018 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-0658-2018 FDA Class II ·initiated 17 Oct 2017

  These finished good kits may contain the incorrect Springwire Guide (SWG).

• • Terminated Z-2334-2017 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.

• • Terminated Z-0639-04 FDA Unclassified (pre-2012) ·initiated 18 Feb 2004

  catheter slips out of the suture wing during use.

1. 14 Sep 2000 Cleared FDA 510(k) K993933
2. 18 Feb 2004 Recall initiated FDA recalls Z-0639-04
3. 9 May 2017 Recall initiated FDA recalls Z-2334-2017
4. 17 Oct 2017 Recall initiated FDA recalls Z-0658-2018
5. 22 Dec 2017 Recall initiated FDA recalls Z-1336-2018
6. 31 Oct 2018 Listed FDA GUDID 10801902143713
7. 21 Apr 2026 Recall initiated FDA recalls Z-2373-2026

Trade name

Arrow

Generic name

Vascular catheter introduction set, nonimplantable

Model / Ref / Catalog

IPN029625, ASK-26142-UNC1

Primary DI / UDI-DI

10801902143713

510(k) Number

K993933 ↗

FDA product code

MPB

GMDN term

Vascular catheter introduction set, nonimplantable

Device class

Class II

Regulation number

876.5540

GUDID distribution status

In Commercial Distribution

Category: Vascular catheter introduction set, nonimplantable

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• 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 →