Accuflate

• 2 recalls, same reason

  • Terminated Z-0913-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010
  • Terminated Z-0914-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

  This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded section of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this

• • Terminated Z-0912-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

  This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded sction of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this fa

510(k) Number

K924273 ↗

FDA Product Code

KCY

Device Class

Class I

Regulation

21 CFR Part 878.5910

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Accuflate Accessorie Cart W/IV Pole and Clamp

  Class I

  FDA 510(k) K924373 Active Cleared 25 Nov 1992

• Light Reflection Rheography

  Class II

  FDA 510(k) K833561 Active Cleared 8 Jan 1985

• Accutest

  Class I

  FDA 510(k) K940615 Active Cleared 19 May 1995

• Disposable Color-Cuffs

  Class I

  FDA 510(k) K890014 Active Cleared 24 Jan 1989

• Clean-Cuff

  Class I

  FDA 510(k) K952038 Active Cleared 11 Jul 1995

• Accuflate

  Class I

  FDA 510(k) K910512 Active Cleared 19 Feb 1991

See all devices from Instrumed, Inc. →