Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 07:26:35 -0500 (CDT)
Subject: Medtronic Neuromodulation INDURA Intrathecal Catheter Recall - Medical Device Safety
Medtronic has recalled it's Neuromodulation INDURA one-piece intrathecal catheters, sutureless pump connector revision kit, and intrathecal catheter pump segment revision kit. This is due to potential misconnections of the sutureless connector catheters and the catheter port on the pump.
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 08:02:56 -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: October 3, 2008 |
The following new items were added to the CDRH web pages on October 2, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Consumer Information on: Akreos® Posterior Chamber Intraocular Lens - P060022 |  |
| | Consumer Information on: COBAS TaqMan HBV Test For Use With The High Pure System - P050028 | |
| Consumer Information on: Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004 | |
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 11:04:15 -0500 (CDT)
Subject: Oncology Drugs Update
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FDA Approves Alimta Injection for Treatment of Metastatic Non-Aquamous Non-Small Cell Lung Cancer (NSCLC).
More information: http://www.fda.gov/cder/Offices/OODP/whatsnew/Alimta.htm
FDA approves iobenguane I 123 injection for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
More information: http://www.fda.gov/cder/Offices/OODP/whatsnew/iobenguane_I_123.htm
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 12:21:07 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Public Workshop: Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States – Transcript
Posted: 10/3/2008
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:13:09 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Recall of m2000sp Instrument - Abbott Molecular, Inc. - 8/25/2008
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:17:55 -0500 (CDT)
Subject: Medical Device Recalls: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters Class I Recall has recently been updated, and is now available.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:19:24 -0500 (CDT)
Subject: Recent Device Approvals: Hoya iSpheric™ Model YA-60BB Intraocular Lens
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Hoya iSpheric™ Model YA-60BB Intraocular Lens (P080004) has recently been posted to the FDA website, and is now available.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:26:49 -0500 (CDT)
Subject: Recent Device Approvals: Akreos® Posterior Chamber Intraocular Lens
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Akreos® Posterior Chamber Intraocular Lens has recently been posted to the FDA website, and is now available.
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:27:37 -0500 (CDT)
Subject: Recent Device Approvals: COBAS TaqMan HBV Test For Use With The High Pure System
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the COBAS TaqMan HBV Test For Use With The High Pure System has recently been posted to the FDA website, and is now available.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:06:06 -0500 (CDT)
Subject: Medical Device Recalls: Nebion HLX-8 Magnetic Resonance Device
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Nebion HLX-8 Magnetic Resonance Device Class I Recall has recently been updated, and is now available.
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:19:03 -0500 (CDT)
Subject: Nebion HLX-8 Magnetic Resonance Device Recall - Medical Device Safety Update
Nebion LLC has recalled the HLX-8 Magnetic Resonance Device because the device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 09:02:58 -0500 (CDT)
Subject: FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food
FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food
Fri, 03 Oct 2008 08:10:00 -0500
The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 14:05:52 -0500 (CDT)
Subject: Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3)
Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3)
Fri, 03 Oct 2008 13:44:00 -0500
Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.
Update : 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 3 Oct 2008 15:24:50 -0500 (CDT)
Subject: FDA MedWatch- Nebion HLX-8 Magnetic Resonance Device: Device Not Approved By FDA
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FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.
Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Class I Recall notice regarding the above issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion
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