Navigation Links
PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve
Date:10/31/2013

rhage within tissue). At this stage distended abdomen was noted. Suction reported to not be effective in reducing the distension. An alternative CO2 valve changed in an attempt to halt the flow of CO2 into the bowel. Upon withdrawal of the colonoscope, CO2 was noted to be flowing from the scope despite valve not being depressed, which is irregular. Patient had abdominal x-ray performed in recovery, a number of small perforations detected. Patient returned to operating theatre, right Hemicolectomy performed. Patient transferred to ICU.

Our investigation into the event concluded there is a possibility that some valves may have been incorrectly assembled. No injuries have been reported in the United States to date. PENTAX Medical Company has notified the FDA of this action.

PENTAX Medical Company distributed the product to Medical Facilities and PENTAX Sales Representatives/ Field Support Staff in the United States.  All affected Medical Facilities in the United States have been notified of the action, have responded, and replacement OF-B194 Valves have been provided by PENTAX Medical Company.

Customers with questions may contact the company via telephone at 1-800-431-5880 extension 2064 Recall Coordinator Paul Silva, between the hours of 9:00am and 5:00pm EST.  Customers may also contact the company via e-mail at PAMC-RA-Group@pentaxmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

Website:

SOURCE PENTAX Medical Company
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. PENTAX Medical And Hitachi-Aloka Medical Continue Joint Innovation And Global Leadership In Endoscopic Ultrasound Systems
2. PENTAX Medical Launches Industrys Highest* Resolution HD+ Imaging Technology For Flexible Endoscopy
3. Concord Medical to Report Third Quarter 2013 Financial Results on November 12, 2013
4. Span-America Medical Systems To Release Fourth Quarter And Fiscal 2013 Results On November 6, 2013
5. The Global Medical Ceramics Market to Grow at a CAGR of 4.25 Percent Over the Period 2012-2016
6. The Medical Device Market: China
7. SAM Medical Products Selected a Winner of EMS World Magazines 2013 Top Innovation Awards
8. MD+DI, the Global MedTech Industry Authority, Announces the 2013 Medical Device Manufacturer of the Year
9. Soterix Medical Inc. announces Phase 3 Clinical Trial for Depression comparing tDCS-LTE against antidepressant drug (Escitalopram)
10. Securus Medical Group Raises $6.5M, Appoints New CEO
11. Nonin Medical Appoints Richard J. Eagle Vice President of Sales
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... and KING OF PRUSSIA, Pa. , May ... has awarded CSL Behring its 2015 Corporate Leadership ... to advancing science and improving the care of the bleeding ... , CEO and Managing Director, CSL Limited, during the NHF ... on May 21. "The National Hemophilia Foundation ...
(Date:5/22/2015)... May 20, 2015 Research and Markets( ... "Guide to Prepare Application Dossiers for Oversea ... Edition) " report to their offering. ... of segment market of the most growth potentiality, ... device manufacturers and producers to penetrate such market. ...
(Date:5/22/2015)... BOSTON , May 22, 2015  In a ... in the U.S., T1D Exchange researchers conclude ... in type 1 diabetes across all age groups, but ... the most up-to-date picture of diabetes treatment, underscoring the ... therapies and technologies that can help type 1 patients ...
Breaking Medicine Technology:National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 2National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 3National Hemophilia Foundation Honors CSL Behring with Corporate Leadership Award 4China Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation 2China Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation 3Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 2Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 3Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 4Study Reveals Poor Disease Control Among Adolescents and Young Adults with Type 1 Diabetes 5
(Date:5/26/2015)... Virginia (PRWEB) May 26, 2015 U.S. ... devices in the United States are extensive and can ... consulting firm that helps medical device companies comply with ... help medical device companies navigate FDA requirements. , ... in the United States can be a lengthy process ...
(Date:5/26/2015)... Carl W. Berk, M.D. and his ... Pinehurst, N.C. have launched a Balloon Sinuplasty website to ... sinusitis and the benefits of Balloon Sinuplasty. , The ... determine if someone is a good candidate for Balloon ... factors that can contribute to chronic nasal congestion. If ...
(Date:5/25/2015)... May 26, 2015 The National ... as a 2015-2016 inductee into its VIP Professional Woman ... prestigious distinction for leadership in dentistry. NAPW is the ... more than 700,000 members and over 200 operating local ... this exceptional group of professional women,” said NAPW President ...
(Date:5/25/2015)... (PRWEB) May 25, 2015 World Patent ... products, announces the Hidee-Hose, an undergarment patent that allays ... "The Global Women's Hosiery industry forecasts the market to ... CEO and Creative Director of World Patent Marketing ... is steering ahead and is expected to maintain its ...
(Date:5/25/2015)... 2015 Thousands of DePuy Pinnacle ... in the federal multidistrict litigation now underway in ... to a Motion filed on May 20th, plaintiffs’ ... Case Management Order pertaining to the Limited Authorization ... Motion seeks the adoption of a new form ...
Breaking Medicine News(10 mins):Health News:FDA Medical Device Regulations: Top 10 Tips for Marketing a Device in the USA 2Health News:FDA Medical Device Regulations: Top 10 Tips for Marketing a Device in the USA 3Health News:FDA Medical Device Regulations: Top 10 Tips for Marketing a Device in the USA 4Health News:Pinehurst Surgical Sinus Center Launches Pinehurst Balloon Sinuplasty Website 2Health News:National Association of Professional Women Inducts Dr. Laquinas Hooked, D.D.S. of General Dentist, Into its VIP Professional Woman of the Year Circle 2Health News:For The Courtesy Of Women's Health And Looks - World Patent Marketing Presents A New Undergarment Patent 2Health News:For The Courtesy Of Women's Health And Looks - World Patent Marketing Presents A New Undergarment Patent 3Health News:Federal DePuy Pinnacle Hip Lawsuits Move Forward, as Plaintiffs Seek to Modify Order Pertaining to Health Authorizations 2Health News:Federal DePuy Pinnacle Hip Lawsuits Move Forward, as Plaintiffs Seek to Modify Order Pertaining to Health Authorizations 3
... trials in humans to treat obesity from a drug derived ... the Managing Director of the company. ,As per ... and each part of the plant has a different effect ... has the power to curb hunger, some other part of ...
... who wear a special kind of no-line bifocal lenses ... who wear more conventional lenses according to a new// ... Ophthalmology & Visual Science (IOVS). ,The ... myopia progression was slower in children wearing progressive-addition lenses ...
... February is National Children's Dental Health Month and as ... its Fifth Annual Give Kids A Smile Day on ... the ADA offers advice for parents and caregivers to ... ,"Preventive dental care has greatly improved the oral health ...
... pill-sized robot that can travel inside your body, can find ... to a computer//. ,After being swallowed, the robot ... Daily Mail. The miniature video camera fitted with the device ... ,The extraordinary invention by Alex Zivanovic of Imperial College, London, ...
... be bustling around hospital wards in as little as ... developed ground-breaking software//. ,The mechanised "nursebots" being ... such as mopping up spillages, taking messages and guiding ... distribute medicines and even monitor the temperature of patients ...
... if its treatment guidelines are followed, the death rate in ... 5%, but it is more common for 20% or over ... the deaths of 1.5 million children every year. ... Professor of Paediatrics in Blantyre, Malawi discusses whether the problem ...
Cached Medicine News:Health News:Good Oral Health Practices Should Begin in Infancy 2Health News:Robot Nurses Ready For Hospitals 'In Three Years' 2
... is a low-price PC-based, 2-8-channel system ... from the retina and the optic ... device, operator monitor, printer, keyboard, mouse, ... All electrical connections are easily to ...
... that allows to see the fundus picture ... Besides it also includes the refractive pupil ... the pupil picture and the fundus image ... especially suited for animal research and retina ...
5 mm...
Cannula and irrigation extension. Overall Length 150 mm (6.25"). Light Curve....
Medicine Products: