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Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

510(k) K143102

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SEKD Traditional NumberK143102 Date24 Jul 2015ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2374-2026 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-1328-2018 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.

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  • Withdrawn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
NIE
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SEKD

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