Accuplace (Tm)

• 4 recalls, same reason

  • Terminated Z-1039-2016 FDA Class II ·initiated 4 Feb 2016
  • Terminated Z-1038-2016 FDA Class II ·initiated 4 Feb 2016
  • Terminated Z-1037-2016 FDA Class II ·initiated 4 Feb 2016
  • Terminated Z-1040-2016 FDA Class II ·initiated 4 Feb 2016

  During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

510(k) Number

K904172 ↗

FDA Product Code

GDF

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Infant Vent Catheter 12001 W/Side Vent Open recall

  Class II

  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

  Class II

  FDA 510(k) K821149 Active Cleared 18 May 1982

• Percutaneous Guidewire Placement Syringe 50505

  Class II

  FDA 510(k) K855089 Active Cleared 18 Feb 1986

• Clearview Blower/Mister Open recall

  Class II

  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

  Class II

  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Aortic Root Cannula W/Integral Press

  Class II

  FDA 510(k) K831591 Active Cleared 30 Jun 1983

See all devices from Dlp, Inc. →