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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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | 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 |  |
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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August 27, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: Integrated Summary of Effectiveness [PDF] or [HTML]
- New and Generic Drug Approvals
- Omnitrope (somatropin [rDNA origin] Injection, Sandoz, Inc., Formulation Revision
- Salonpas Patch (methyl salicylate and menthol), Hisamitsu Pharmaceutical Co., Inc., Package Change
- Trandolapril Tablets, Dr. Reddy's Laboratories, Ltd., Approval
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
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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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