Navigation Links
B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)
Date:10/27/2010

IRVINE, Calif., Oct. 27 /PRNewswire/ -- B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. As a result, B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

(Logo: http://photos.prnewswire.com/prnh/20081022/NYW008LOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081022/NYW008LOGO)

B. Braun has not received any reports of adverse events regarding the B. Braun finished products manufactured using this API.

Based on current information, the recalled lots do not pose a significant health risk; however, B. Braun is performing this voluntary recall as a precautionary measure with the support of the U.S. Food and Drug Administration (FDA).

Heparin is a blood thinner used to treat and prevent blood clots. The voluntary recall affects the following seven Finished Product (FP) lots manufactured in 2008 by B. Braun Medical Inc. and distributed nationwide to distributors and direct healthcare provider customers. Product Name

B. Braun Catalog Number

B. Braun Lot Number

B. Braun Manufacture Date

Expiration Date25,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL

P5771

J8D674

4/15/2008

10/31/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D676

4/17/2008

10/31/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D677

4/17/2008

10/31/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D702

4/30/2008

10/31/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8D703

4/30/2008 – 5/1/2008

10/31/201025,000 Units Heparin in 5% Dextrose Injection, 50 Units/mL

P5771

J8E462

5/8/2008

11/30/20101,000 Units Heparin in 0.9% Sodium Chloride Injection, 2 Units/mL

P8721

J8E539

5/15/2008

11/30/2010B. Braun is notifying its distributors and customers by certified mail and is arranging for return of all recalled product. Customers who have product from the recalled product lots in their possession should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers may contact B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. to 7 p.m. ET for instructions for handling the affected product and to arrange for replacement product.  

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178 

  • About B. BraunB. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company's "Sharing Expertise®" philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives.

    Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B. Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals. For more information, call 800-227-2862, email us at inquiry.us@bbraun.com or visit B. Braun at www.bbraunusa.com.


    '/>"/>

    SOURCE B. Braun Medical Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. B. Braun Medical Inc. to Demonstrate Infusion Systems Technologies at HIMSS 2009 Interoperability Showcase
    2. B. Braun Awarded Contract With HealthTrust Purchasing Group to Provide Pain Management Solutions
    3. B. Braun and Amerinet Sign to Expand Infusion Therapy Offerings
    4. MEDRAD and B. Braun Melsungen AG Collaborate to Promote Breakthrough Medical Treatment for Cardiovascular Disease
    5. B. Braun Introduces WHIN(R) Safe Huber Needle
    6. B. Braun Infusion Systems Complete Interoperability Test for HIMSS10 Interoperability Showcase
    7. B. Braun Renal Therapies Division Announces Availability of Adimea
    8. FDA Approves Cefepime for Use In B. Brauns DUPLEX(R) System
    9. Health Robotics Re-Acquires CytoCares European Rights from B. Braun Melsungen AG for Undisclosed Consideration
    10. New Technology Center Increases B. Brauns Infusion Pump Capacity
    11. B. Braun Large Volume Heparin Infusion Solutions Now Available
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) , ... firsts,: , TwinLink™ - the first dual ...
    (Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
    (Date:6/23/2016)... FRANKLIN, Tenn. , June 23, 2016 ... for automating, integrating and transforming the patient ... launch of several innovative new products and ... depth of its revenue cycle offerings. These ... establish more efficient workflows, remain compliant in ...
    Breaking Medicine Technology:
    (Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
    (Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
    (Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
    (Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are ... for this recognition are considered among the top 2 percent of lawyers practicing within ... of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, ...
    (Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
    Breaking Medicine News(10 mins):