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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 05:49:04 -0600 (CST)
Subject: CDRH New Update

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

Date: January 30, 2008

The following new items were added to the CDRH web pages on January 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 08:15:20 -0600 (CST)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 08:49:52 -0600 (CST)
Subject: Medical Device Recalls: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the  AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes Class I Recall has recently been updated, and is now available.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 14:05:47 -0600 (CST)
Subject: Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products (Jan. 29)

Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products (Jan. 29)
Wed, 30 Jan 2008 12:30:00 -0600

NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jan 2008 06:20:59 -0600 (CST)
Subject: CDRH New Update

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

Date: January 29, 2008

The following new items were added to the CDRH web pages on January 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Information on Wrinkle Fillers

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Jan 2008 08:05:09 -0600 (CST)
Subject: Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials (Jan. 25)

Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials (Jan. 25)
Tue, 29 Jan 2008 06:42:00 -0600

Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.

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This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jan 2008 05:43:26 -0600 (CST)
Subject: CDRH New Update

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

Date: January 28, 2008

The following new items were added to the CDRH web pages on January 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Class I Medical Device Recall: Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Jan 2008 10:05:12 -0600 (CST)
Subject: Shiloh Farms Recalls Shiloh Farms Organic Unhulled Sesame Seeds Because of Possible Health Risk (Jan. 28)

Shiloh Farms Recalls Shiloh Farms Organic Unhulled Sesame Seeds Because of Possible Health Risk (Jan. 28)
Mon, 28 Jan 2008 08:26:00 -0600

This product comes in a 12 oz blue and white 5" x 8" plastic bag with a Shiloh Farms logo and USDA organic symbol. The UPC bar code number is 047593303545. The firm's name and address appears on the back of the plastic bag. Product distributed between November 1, 2007 and January 25, 2008 is being recalled. Only product with lot codes 17503 and 17133 are affected.

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Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

CDRH Blog

This blog serves the purpose of collecting all e-mail newsletters published by the US FDA CDRH - providing a web-based archive for all users interested. Feel free to discuss and comment on FDA CDRH related issues.