I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)

• • Terminated Z-2111-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2008

  I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t

• 2 recalls, same reason

  • Terminated Z-0584-06 FDA Unclassified (pre-2012) ·initiated 17 Jan 2006
  • Terminated Z-0585-06 FDA Unclassified (pre-2012) ·initiated 17 Jan 2006

  The sterile pack may contain the wrong infusion pump inside.

510(k) Number

K052117 ↗

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. →