I-Flow Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 42
- FDA recalls
- 18
At a glance
Market reach
- United States
- FDA recalls
What I-Flow Corp. makes
I-Flow Corp. manufactures a range of infusion and catheter products, including the Soaker Catheter, Painbuster Infusion Kit, Titan Driver 60cc administration set, Paragon Infusion System, Sidekick Infusion Kit, elastomeric pumps such as the I-Flow Elastomeric Pump with Bolus and various models (On-Q, Painbuster, C-Block, HomePump, EasyPump), HomePump C-Series and One-Step KVO devices, fixed flow rate gravity administration sets, a multi‑drug infusion system, and personal infusers VIVUS 50 and VIVUS 100.
All of these devices are classified as Class II medical devices and are listed in the FDA 510(k) database. I-Flow Corp. is based in the United States.
Catalogue
Search and filter all 42 devicesFDA recalls
FDA recall records list 18 recalls initiated by I-Flow Corp., the earliest on 2002-08-19 and the most recent on 2012-06-01. By recorded status: 18 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 1 Jun 2012 Z-1444-2013 Class II Terminated I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
- 1 Jun 2012 Z-1445-2013 Class II Terminated I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
- 8 May 2012 Z-2253-2012 Class I Terminated It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
2011
- 15 Apr 2011 Z-2860-2011 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 15 Apr 2011 Z-2860-2011 Unclassified (pre-2012) Terminated 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.
2008
- 1 Aug 2008 Z-2249-2009 Unclassified (pre-2012) Terminated I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
- 1 Aug 2008 Z-2250-2009 Unclassified (pre-2012) Terminated I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. Used to provide an optional filling device for the Easypump.
- 14 Feb 2008 Z-2133-2008 Unclassified (pre-2012) Terminated Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
- 12 Feb 2008 Z-1869-2008 Unclassified (pre-2012) Terminated 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.
- 11 Feb 2008 Z-2111-2009 Unclassified (pre-2012) Terminated 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
Full distribution text
2007
- 27 Mar 2007 Z-0057-2008 Unclassified (pre-2012) Terminated Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.
Show all 18 recalls
2006
- 29 Nov 2006 Z-0358-2007 Unclassified (pre-2012) Terminated The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
- 17 Jan 2006 Z-0584-06 Unclassified (pre-2012) Terminated The sterile pack may contain the wrong infusion pump inside.
- 17 Jan 2006 Z-0585-06 Unclassified (pre-2012) Terminated The sterile pack may contain the wrong infusion pump inside.
2003
- 23 Aug 2003 Z-0313-04 Unclassified (pre-2012) Terminated Some pumps run at 2 ml/hr instead of 0.5 ml/hr.
- 18 Mar 2003 Z-0741-03 Unclassified (pre-2012) Terminated Overinfusion due to misassembly.
- 5 Mar 2003 Z-0709-03 Unclassified (pre-2012) Terminated Wrong component may result in over infusion of medications.
- 4 Mar 2003 Z-0687-03 Unclassified (pre-2012) Terminated Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
2002
- 19 Aug 2002 Z-0312-04 Unclassified (pre-2012) Terminated Slower than expected infusion of medications, such as antibiotics.
Frequently asked questions
How many devices does I-Flow Corp. have in the registry?
The registry currently lists 42 devices for I-Flow Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list I-Flow Corp.'s devices?
Among its 42 most recently registered devices, I-Flow Corp. has devices listed in FDA 510(k) (42 devices).
What risk classes do I-Flow Corp.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for I-Flow Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for I-Flow Corp.?
FDA recall records list 18 recalls initiated by I-Flow Corp., the most recent initiated on 2012-06-01. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from I-Flow Corp. in the registry?
The most recently registered devices listed for I-Flow Corp. include SOAKER CATHETER, PAINBUSTER INFUSION KIT, TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET and PARAGON INFUSION SYSTEM.