Saturday, August 30, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin


Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 09:01:47 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: August 28, 2008

The following new items were added to the CDRH web pages on August 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Summary Information for: Attain StarFix Model 4195 Lead PDF

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Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 10:18:27 -0500 (CDT)
Subject: CDER New 8/27/2008

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

August 27, 2008


Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 13:14:58 -0500 (CDT)
Subject: Pacific Consolidated Industries Oxygen Storage Tank Recall - Medical Device Safety

Pacific Consolidated Industries LLC has recalled the Mobile Oxygen Storage Tank due to the possibility that the pressure gauge may rupture and cause the tank to catch fire.


Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 13:45:35 -0500 (CDT)
Subject: Medical Device Recalls: Pacific Consolidated Industries Mobile Oxygen Storage Tank

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank Class I Recall has recently been updated, and is now available.


Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 17:02:50 -0500 (CDT)
Subject: Enforcement Report for August 27, 2008

Enforcement Report for August 27, 2008
Wed, 27 Aug 2008 11:30:00 -0500

Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 28 Aug 2008 13:52:41 -0500 (CDT)
Subject: FDA MedWatch -Mobile Oxygen Storage Tank- Class I Recall Because The Device's Pressure Gauge May Rupture And May Catch Fire

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall Notice regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Pacific


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