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:2/24/2017)... N.C. , Feb. 24, 2017 ... exploring ways to increase their self-service capabilities to ... Care Providers (HCPs). New research from ... pharma organizations have developed self-service website portals where ... This is just one of many findings to ...
(Date:2/24/2017)... , Australie, le 24 février 2017 ITL Limited, ( ... diversifiée innovante, est ravie d,annoncer les excellents résultats semestriels ... période précédente correspondante. Une présentation complète « Résultats et mise ... consultée ici . Faits marquants ... 2,12 millions $ (Déc. 2015 : 1,04 million $ ; en hausse de 104 %) ...
(Date:2/24/2017)... STOCKHOLM , Feb 24, 2017 ... Nomination Committee,s proposal for a new Board of Directors ... Meeting. The 2016-2017 Nomination Committee comprises representatives of the ... third quarter of 2016 who have accepted a seat ... Board. The composition of the 2016-2017 Nomination Committee was ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... ... which specializes in thought leadership , media relations, social media, content marketing ... that will be powered through Act-On, an intuitive marketing automation platform. , Rosica ...
(Date:2/23/2017)... TX (PRWEB) , ... February 23, 2017 , ... ... announced an official 2017 partnership with The Jensie Gran Fondo of Marin. For ... and UVB rays with Thinksport’s broad-spectrum, mineral-based sunscreen. , “We are thrilled to ...
(Date:2/23/2017)... ... 2017 , ... The Lymphoma Research Foundation (LRF) – the ... the lymphoma community through a comprehensive series of education programs, outreach initiatives and ... Beach to host its Swirl: Miami Wine Tasting Event on March 28, 2017. ...
(Date:2/23/2017)... ... 2017 , ... Los Angeles-based weight loss surgeon Michael Feiz, M.D., F.AC.S. will ... to Hot,” which will begin airing on February 24, 2017. The show chronicles the ... 2012 reality television series, “Here Comes Honey Boo Boo.” The earlier series from TLC ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... content provider for the National Institute for Health and Care Excellence ... organizations in the National Health Service (NHS) to search, order and purchase medical ...
Breaking Medicine News(10 mins):