Cook Nephrostomy Dilation Balloon Catheter Set

• 2 recalls, same reason

  • Terminated Z-1238-2016 FDA Class II ·initiated 27 Jan 2016
  • Terminated Z-1237-2016 FDA Class II ·initiated 27 Jan 2016

  Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.

510(k) Number

K024050 ↗

FDA Product Code

LJE

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• 3 Way Silicone Foley Balloon Catheter

  Class II

  FDA 510(k) K091767 Active Cleared 9 Oct 2009

• Aq Hydrophilic Dilators

  Class II

  FDA 510(k) K961904 Active Cleared 18 Oct 1996

• Bipolar Cutter

  Class II

  FDA 510(k) K955618 Active Cleared 22 Jan 1996

• Rutner Biopsy Device

  Class II

  FDA 510(k) K950810 Active Cleared 6 Mar 1995

• CO2 Pneumo-Dissector

  Class II

  FDA 510(k) K972647 Active Cleared 10 Apr 1998

• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

  Class II

  FDA 510(k) K014160 Active Cleared 8 Feb 2002

See all devices from Cook Urological, Inc. →