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by Arrow International (Subsidiary of Teleflex Inc.)

510(k) K121941

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 · Special NumberK121941 Date7 Sep 2012ClearedStatusActive

Recalls

10 recalls · 1 ongoing · FDA

    • Ongoing Z-2591-2023 FDA Class II initiated 10 Aug 2023

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    • Terminated Z-0690-2018 FDA Class II initiated 17 Oct 2017

    The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.

    • Terminated Z-0601-2018 FDA Class II initiated 25 Jul 2017

    Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

  • 2 recalls, same reason

    • Terminated Z-0180-2018 FDA Class II initiated 1 Jun 2017
    • Terminated Z-0181-2018 FDA Class II initiated 1 Jun 2017

    There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

    • 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.

    • Terminated Z-2489-2015 FDA Class II initiated 30 Jul 2015 on shared 510(k) K121941

    saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

    • Terminated Z-2462-2015 FDA Class II initiated 30 Jul 2015

    the catheter peel-away component hub tabs may prematurely detach. One injury reported.

    • Terminated Z-1030-2015 FDA Class III initiated 9 Jan 2015 on shared 510(k) K121941

    Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

    • Terminated Z-1494-2014 FDA Class II initiated 24 Mar 2014

    Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm 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

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