Celerity Sysyem

• • Terminated Z-1137-2017 FDA Class II ·initiated 7 Sep 2016 ·on shared 510(k) K140799

  The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.

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

510(k) Number

K140799 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Medcomp Gen III Power Injectable Port Open recall

  Class II

  FDA 510(k) K132177 Active Cleared 12 Dec 2013

• ArchFlo CT Midline

  Class II

  FDA 510(k) K171483 Active Cleared 15 Dec 2017

• Medcomp Vascu-Picc with Valve

  Class II

  FDA 510(k) K130897 Active Cleared 22 Oct 2013

• C3 Wave

  Class II

  FDA 510(k) K143238 Active Cleared 24 Apr 2015

• 20G x 5/8 Pro-Lock CT Safety Infusion Set

  Class II

  FDA 510(k) K171333 Active Cleared 18 Jul 2017

• Dignity Dual Port

  Class II

  FDA 510(k) K153238 Active Cleared 15 Mar 2016

See all devices from Medcomp (Medical Components, Inc.) →