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• • 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.

• • Terminated Z-1809-2019 FDA Class II ·initiated 23 Apr 2019

  Lidstock states the incorrect expiration date for the product

• • Terminated Z-2025-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-2489-2015 FDA Class II ·initiated 30 Jul 2015 ·on shared 510(k) K130876

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

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

510(k) Number

K130876 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• UltraFlex IAB Open recall

  Class II

  FDA 510(k) K190101 Active Cleared 28 Jun 2019

• Silicone Coated Guidewire

  Class II

  FDA 510(k) K041740 Active Cleared 15 Oct 2004

• Arrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter Open recall

  Class II

  FDA 510(k) K071538 Active Cleared 30 Aug 2007

• Step-Tip Chronic Hemodialysis Catheter

  Class II

  FDA 510(k) K040666 Active Cleared 14 May 2004

• Fiberoptix IAB

  Class II

  FDA 510(k) K190117 Active Cleared 13 Jun 2019

• StimuCath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK

  Class II

  FDA 510(k) K030937 Active Cleared 23 Apr 2003

See all devices from Arrow International, Inc. →