Arrow IPN029793

• FDA 510(k) K011761 decided 31 Oct 2001 Active
• FDA GUDID UDI-DI 10801902144512 listed 21 Dec 2018 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. 6 Aug 2014 Recall initiated FDA recalls Z-0066-2015
2. 27 Aug 2015 Recall initiated FDA recalls Z-2825-2015
3. 9 May 2017 Recall initiated FDA recalls Z-2333-2017
4. 27 Nov 2017 Recall initiated FDA recalls Z-1000-2018
5. 27 Nov 2017 Recall initiated FDA recalls Z-1002-2018
6. 22 Dec 2017 Recall initiated FDA recalls Z-1324-2018
7. 11 Apr 2018 Recall initiated FDA recalls Z-1983-2018
8. 21 Dec 2018 Listed FDA GUDID 10801902144512
9. 6 Aug 2019 Recall initiated FDA recalls Z-2555-2019
10. 21 Apr 2026 Recall initiated FDA recalls Z-2385-2026

2 earlier events are in the sections above.

Trade name

Arrow

Generic name

Vascular catheter introduction set, nonimplantable

Model / Ref / Catalog

IPN029793, ASK-29903-UCL1

Primary DI / UDI-DI

10801902144512

510(k) Number

K011761 ↗

FDA product code

DYB

GMDN term

Vascular catheter introduction set, nonimplantable

Device class

Class II

Regulation number

870.1340

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 →