Navigation Links
Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
Date:10/6/2009

MCALLEN, Texas, Oct. 6 /PRNewswire/ -- Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 - March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160. This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.

(Photo: http://www.newscom.com/cgi-bin/prnh/20091006/NY88437 )

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.

Unomedical notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.

Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

About Unomedical

Unomedical is a provider of medical devices with global operations. For more information, please visit www.unomedical.com.

    Media Contacts:

    Peter Duda or Hallie Bozzi
    Weber Shandwick
    212-445-8287
    unomedical@webershandwick.com
    9am - 6pm (EST)

    Customer Contacts:

    Americas
    Raymond Mendoza
    1-800-634-6003
    8:00am - 5:30pm Mon-Thurs, 8:00am - 1:00pm Fri (CST)

    Europe
    Betina Simonsen
    +45 4810 3036
    8:00am - 4pm Mon-Fri (CET)

    Asia
    Winnie Hui
    + 65 6593 1568
    9:00am - 5:00pm Mon-Fri (SGT)

    Russia
    Michael Martikhin
    +7 49 57487884
    8:30am - 5pm Mon-Fri (MSK)

SOURCE Unomedical Inc.


'/>"/>
SOURCE Unomedical Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Issues Complete Response Letter for Carisbamate
2. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
3. Society of Gynecologic Oncologists Issues White Paper on HPV Vaccines Impact on Cervical Cancer Prevention
4. Pennsylvania Agriculture Department Issues Quarantine for Allegheny County Horse Stable
5. FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
6. Avon Protection Systems Issues Correction/Clarification on ST53 SCBA System
7. Pharmos Issues Business Update on Dextofisopam Trial and Financing
8. U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
9. FDA Issues a Complete Response Letter for Lillys Olanzapine LAI for Treatment of Schizophrenia in Adults
10. Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients
11. MatTeks EpiDerm In Vitro Tissues Headed for Validation in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
Breaking Medicine News(10 mins):