Non-Sterile, Single/Souble Lumen-Cath

• • Ongoing Z-1367-2026 FDA Class II ·initiated 12 Dec 2025

  Due to damage to outer tray that can potentially compromise the sterile barrier

• 2 recalls, same reason

  • Terminated Z-0909-2013 FDA Class II ·initiated 21 Feb 2013 ·via K830233, on the same 510(k)
  • Terminated Z-0910-2013 FDA Class II ·initiated 21 Feb 2013 ·via K830233, on the same 510(k)

  Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K830233 ↗

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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