On-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump

• • Terminated Z-2860-2011 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011

  The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.

• • Terminated Z-2133-2008 FDA Unclassified (pre-2012) ·initiated 14 Feb 2008

  Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.

• • Terminated Z-1869-2008 FDA Unclassified (pre-2012) ·initiated 12 Feb 2008

  The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.

510(k) Number

K063530 ↗

FDA Product Code

MEB

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Soaker Catheter

  Class II

  FDA 510(k) K994374 Active Cleared 3 Mar 2000

• Painbuster Infusion Kit

  Class II

  FDA 510(k) K982946 Active Cleared 18 Nov 1998

• Titan Driver 60cc, 30 Minute Administration Set

  Class II

  FDA 510(k) K953028 Active Cleared 28 Sep 1995

• Paragon Infusion System

  Class II

  FDA 510(k) K020251 Active Cleared 15 Feb 2002

• Sidekick Infusion Kit

  Class II

  FDA 510(k) K990425 Active Cleared 23 Apr 1999

• I-Flow Elastomeric Pump with Bolus

  Class II

  FDA 510(k) K023318 Active Cleared 18 Oct 2002

See all devices from I-Flow Corp. →