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

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 06:26:15 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: June 2, 2008

The following new items were added to the CDRH web pages on May 30, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters.
	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability.
	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability.
	Federal Register: General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device.
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability.
	Federal Register: Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System.
	Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Minutes

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 14:25:04 -0500 (CDT)
Subject: FDA MedWatch - The June 2008 FDA Patient Safety News is Now Available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the June 2008 edition include:

Inflammatory Masses with Synchromed EL, Sychomed II and IsoMed Implantable Infusion Pumps

Medtronic updates patient management and treatment recommendations for patients receiving intrathecal drugs…

 

FDA Studying Potential Safety Issues with Several Drugs

Ongoing safety reviews of CellCept (mycophenolate mofetil), Myfortic (mycophenolic acid), Singulair (montelukast), and the Spiriva Handihaler (tiotropium)…

 

Neupro (rotigotine) Patches Recalled

Rotigotine may crystallize, which may affect absorption of the drug through the skin…

 

Avoid Using ReadyMED Infusion Pumps with Cubicin

Impurity isolated from reconstituted Cubicin that was stored in ReadyMED pumps…

 

Getting the Most Out of Blood Glucose Meters

Tips to help people with diabetes get accurate results from their glucose meters…

 

 

For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@fda.gov

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 14:35:20 -0500 (CDT)
Subject: FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation

Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:

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

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