Skip to content

Arrw Evolution

by Arrow International (Subsidiary of Teleflex Inc.)

510(k) K112896

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112896 Date10 May 2012ClearedStatusActive

Recalls

11 recalls · 1 ongoing · FDA

    • Ongoing Z-2378-2026 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.

  • 4 recalls, same reason

    • Terminated Z-1822-2019 FDA Class II initiated 23 Apr 2019
    • Terminated Z-1820-2019 FDA Class II initiated 23 Apr 2019
    • Terminated Z-1811-2019 FDA Class II initiated 23 Apr 2019
    • Terminated Z-1819-2019 FDA Class II initiated 23 Apr 2019

    Lidstock states the incorrect expiration date for the product

    • Terminated Z-1327-2018 FDA Class II initiated 22 Dec 2017 on shared 510(k) K112896

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

    • Terminated Z-0996-2018 FDA Class II initiated 27 Nov 2017

    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-2698-2017 FDA Class II initiated 12 Jun 2017

    Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

    • Terminated Z-2331-2017 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-1705-2017 FDA Class II initiated 3 Mar 2017

    Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

    • Terminated Z-0207-2016 FDA Class II initiated 16 Oct 2015

    Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

See all devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.) →