Navigation Links
Cardinal Health, FDA Amend Infusion Pump Consent Decree
Date:2/17/2009

DUBLIN, Ohio, Feb. 17 /PRNewswire-FirstCall/ -- Cardinal Health today announced it has reached agreement with the Food and Drug Administration (FDA) on an amended consent decree regarding the company's infusion pump products.

Cardinal Health has operated under a consent decree since February 2007 for its Alaris(R) SE pumps, which resulted in the company implementing a new quality system on April 2, 2008. Under the amended agreement, which is subject to approval by the U.S. District Court for the Southern District of California, Cardinal Health will conduct a thorough review of its broader line of infusion pump products within 60 days and submit a corrective action plan to the FDA that outlines all planned modifications to any infusion pump products. Within 100 days, the company will have an independent expert inspect and certify whether the company's infusion pump operations are in conformity with the Quality System Regulation and certain other provisions of the Federal Food, Drug, and Cosmetic Act. Also within 100 days, the company will have an independent expert inspect and certify whether its recall procedures and all ongoing infusion pump recalls are in compliance with the Act and determine whether additional remedial action should be taken.

The FDA alleges in the amended consent decree that based on a January 2008 inspection, certain Cardinal Health infusion pumps do not satisfy the standards of the Act. The amended agreement does not impact the company's ability to market and sell its broader line of infusion pump products, except for the Alaris SE pump.

"We are taking the FDA's observations -- and our obligation to deliver safe and effective products -- very seriously," said David Schlotterbeck, Cardinal Health vice chairman and chief executive officer of Clinical and Medical Products. "We will continue to improve our systems as we prepare to meet the additional requirements of the a
'/>"/>

SOURCE Cardinal Health, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Cardinal Health Announces New Name for Spinoff Company
2. Cardinal Rigali to Congress: Keep Existing Pro-Life Laws
3. Cardinal Health Reports Second Quarter Results
4. Cardinal Health Updates FY09 Outlook
5. Cardinal Health, SRI Surgical Sign Five-Year Agreement For Surgical Kits
6. Cardinal Health Announces Preliminary Shareholder Voting Results at Annual Meeting
7. Cardinal Health Reports First Quarter Results
8. Positive Picture of Independent Community Pharmacies Emerges With Release of 2008 NCPA Digest, Sponsored by Cardinal Health
9. Cardinal Health Reports Fiscal 2008 Results, Provides Fiscal 2009 Outlook
10. Cardinal Health Declares Regular Quarterly Dividend
11. Cardinal Health Expands Leader(R) Offering To Help Independent Pharmacies Strengthen Patient Relationships, Solidify Role As Local Health Care Experts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/20/2014)... 20, 2014 DePuy Pinnacle hip ... version of the artificial hip system was defectively ... federal courts, Bernstein Liebhard LLP reports. According to ... Superior Court on December 2nd, counsel in 10 ... of plaintiffs on November 19, 2014, with depositions ...
(Date:12/20/2014)... -- The holidays can be anything but joyous for ... scented candles and other allergy triggers. "The dust ... been packed away in dank basements or dusty attics ... Dr. Rachna Shah, an affiliate faculty member at Loyola ... news release. Shah, who is also an allergist ...
(Date:12/20/2014)... Office Urgent Care of Paramus, New Jersey has served the ... treated over 40,000 patients while carrying out their mission of ... Paramus area. , For 2015, the practice is proud ... board certified physicians: Christine Milosis MD, Sandra Ugras Rey DO, ... work tirelessly to carry out The Doctor’s Office Urgent ...
(Date:12/20/2014)... York, New York (PRWEB) December 20, 2014 ... continue to move forward in U.S. courts, ... new study which suggests that children treated with ... a hormone linked to breast development and lactation. ... looked at 34 children and adolescents who began ...
(Date:12/20/2014)... York, NY (PRWEB) December 20, 2014 The ... has caused quite a stir, not only in Hollywood, but ... on December 18th , the ripples of that attack are ... executives’ very jobs at risk. But they are not ... correspondences exposed could be in for some embarrassing times ahead, ...
Breaking Medicine News(10 mins):Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 2Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 3Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 4Health News:Holiday Trimmings Can Trigger Allergies 2Health News:The Doctor's Office Urgent Care Adds 3 New Physicians to Their Growing Medical Team 2Health News:Risperdal Lawsuit News: Bernstein Liebhard LLP Notes Publication of Study Suggesting Medication May Raise Prolactin Levels in Children 2Health News:Risperdal Lawsuit News: Bernstein Liebhard LLP Notes Publication of Study Suggesting Medication May Raise Prolactin Levels in Children 3Health News:Risperdal Lawsuit News: Bernstein Liebhard LLP Notes Publication of Study Suggesting Medication May Raise Prolactin Levels in Children 4Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 2Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 3Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 4Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 5
... many health,recommendations in the media these days that it,s often ... make for better,health in the year ahead. ISSA polled their ... for their top,recommendations for the 10 best things their clients ... are the results of that survey:, 1 ...
... SMTS ) will release its financial results for the ... the opening of the market on,Wednesday, January 23, 2008. ... a conference call that will be webcast live at ... call, Bruce Barrett, Somanetics, president and chief,executive officer, and ...
... people cut down on excessive alcohol use , FRIDAY, Jan. ... dangers of alcohol abuse by an emergency room doctor or ... three drinks a week, new research shows. , Researchers trained ... tool, then applied it to almost 7,800 emergency patients in ...
... Inc. (NYSE:,DVA) announced today that it and Southwest ... to provide dialysis and vascular,access services, as well ... greater Phoenix area. The partnership will own and ... provide patients with,access to all available treatment modalities. ...
... precise cancer treatments ... form of volumetric arc therapy, PALO ALTO, Calif., ... has received FDA 510(k) clearances for its RapidArc(TM),radiotherapy technology, ... intensity-modulated radiation therapy (IMRT) two to,eight times faster and ...
... Pharmaceuticals,Inc. (NYSE: BRL ) today announced that ... from the U.S. Food and Drug Administration,(FDA) for ... hydrochloride) Tablets, 1mg (eq to 1 mg base). ... Roche,s patent on,December 28, 2007, and plans to ...
Cached Medicine News:Health News:International Sports Sciences Association's Ten Best Resolutions for Better Health in 2008 2Health News:Somanetics Corporation to Release Fourth Quarter and Fiscal 2007 Financial Results and Host Conference Call January 23, 2008 2Health News:Brief Chat With ER Docs Can Curb Problem Drinking 2Health News:Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology 2Health News:Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology 3Health News:Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology 4Health News:Barr Receives Approval for Generic KYTRIL(R) Tablets, 1mg (Base) 2Health News:Barr Receives Approval for Generic KYTRIL(R) Tablets, 1mg (Base) 3
(Date:12/19/2014)... Fla. , Dec. 19, 2014 Breckenridge ... a multi-product agreement with MSN Laboratories Pvt. Ltd. ( ... MSN expect to commercialize several new ANDAs.  Under the ... supply the products exclusively to Breckenridge for the U.S. ... under its label.  Breckenridge and MSN have agreed to ...
(Date:12/19/2014)... CARDIFF-BY-THE-SEA, Calif. , Dec. 19, 2014 ... ;  Sorrento), an oncology company developing new treatments ... a privately-held immuno-oncology company developing proprietary Neukoplast ® ... therapy, announced today that the companies have entered ... generation CAR-TNK™ (pronounced as "Car-Tank") immunotherapies for the ...
(Date:12/19/2014)... BURLINGTON, Mass. , Dec. 18, 2014  Decision ... the United States will increase ... Growth will be primarily driven by expansion in the ... direct energy devices will be increasingly adopted due to ... launched. Other key findings from Decision Resources ...
Breaking Medicine Technology:Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5U.S. Laparoscopic Device Market Will Reach Over $4.3 Billion by 2023 2U.S. Laparoscopic Device Market Will Reach Over $4.3 Billion by 2023 3
... 10, 2012 Cyberonics, Inc. (NASDAQ: CYBX ), ... management of epilepsy, today announced it will participate in the ... 2012, in New York. Greg Browne, Senior Vice ... Eastern Time.  A live audio webcast of the presentation can ...
... Feb. 10, 2012  Zacks highlights commentary from People and Picks ... http://photos.prnewswire.com/prnh/20101027/ZIRLOGO ) For more Voice of the People, ... Market Percolates, Doubters Wait They,re coming ... course the troll community. They,re telling you the market is ...
Cached Medicine Technology:Zacks' Voice of the People highlights opportunities with Walgreen, Occidental Petroleum and Brown & Brown 2Zacks' Voice of the People highlights opportunities with Walgreen, Occidental Petroleum and Brown & Brown 3
... mg/kg sulfate (SO 4 ) ≤ 1000 mg/kg Cation ... Co ≤ 5 mg/kg Cr ≤ 10 mg/kg Cu ... 5 mg/kg Mg ≤ 5 mg/kg Mn ≤ 5 ... Pb ≤ 5 mg/kg Zn ≤ 5 mg/kg Special ...
Application: Capable of separating DNA fragments of 50 to 1000 bp on a 3% gel Solubility: water 15 mg/mL, clear, colorless, hot Special grade: for molecular biology Suitab tst: electrophoresis te...
Inquire...
Inquire...
Medicine Products: