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Arrow IPN000162

by Teleflex Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801902001504 UDI-DI Date5 Feb 2016ListedStatusListed GUDID: in commercial distribution

Recalls

17 recalls · 1 ongoing · FDA

    • 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-1242-2020 FDA Class II initiated 20 Dec 2019

    Product lidstock contains the incorrect expiration date for the product

    • Terminated Z-2576-2018 FDA Class II initiated 23 May 2018

    Product contains dry natural rubber latex. Label states Latex Free.

  • 5 recalls, same reason

    • Terminated Z-2011-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-1977-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-1976-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2031-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2032-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

    • Terminated Z-1329-2018 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-1158-2018 FDA Class II initiated 14 Nov 2017

    Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

    • Terminated Z-1287-2018 FDA Class II initiated 26 Oct 2017

    The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

    • Terminated Z-2329-2017 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-0066-2015 FDA Class II initiated 6 Aug 2014 on shared 510(k) K780532

    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-1713-2014 FDA Class II initiated 14 Apr 2014

    Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.

    • Terminated Z-0468-2014 FDA Class II initiated 9 Oct 2013

    There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

    • Terminated Z-2048-2011 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.

    • Terminated Z-0936-2011 FDA Unclassified (pre-2012) initiated 20 Dec 2010

    Packaging may have been compromised, and sterility of product cannot be guaranteed.

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Arrow
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
IPN000162, CL-08503
Primary DI / UDI-DI
00801902001504
510(k) Number
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
Size
Width — 7.5 Centimeter
Catheter Gauge — 5 French

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K780532)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No