Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters

• • Ongoing Z-2376-2026 FDA Class I ·initiated 21 Apr 2026 ·on shared 510(k) K970864

  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-1290-2022 FDA Class II ·initiated 5 May 2022

  Gravity flow rates on the affected product lidstock are incorrect.

• 2 recalls, same reason

  • Terminated Z-1672-2009 FDA Unclassified (pre-2012) ·initiated 8 May 2009
  • Terminated Z-1671-2009 FDA Unclassified (pre-2012) ·initiated 8 May 2009

  Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.

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

510(k) Number

K970864 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Arrow Picc-Peripherally Inserted Central Catheter

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  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

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  FDA 510(k) K071998 Active Cleared 26 Sep 2007

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