FDA RECALLS+ for October 2005

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FDA News Digest

October 17, 2005

 

 

IN THIS WEEK'S ISSUE

 

-- Poor Manufacturing Prompts Seizure of Baxter Infusion Pumps

-- FDA Offers Patient Information on Recently Approved Medical Devices

-- Recalls/Safety Alerts

-- Upcoming Public Meetings

-- Question of the Week

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Poor Manufacturing Prompts Seizure of Baxter Infusion Pumps

 

At FDA's request, U.S. marshals have seized more than 4,000 infusion pumps marketed by Baxter Healthcare Corp. after the company continually failed to follow requirements for manufacturing medical devices. The seizure covered three pump models: SYNDEO PCA Syringe Pump, Colleague Volumetric Infusion Pump, and Colleague CX Volumetric Infusion Pump.

http://www.fda.gov/bbs/topics/news/2005/new01242.html

 

FDA Offers Patient Information on Recently Approved Medical Devices

 

FDA's Center for Devices and Radiological Health has published online consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices:

 

-- SJM Biocor and Biocor Supra Valves

Intended use: as a replacement for diseased or defective heart valves

http://www.fda.gov/cdrh/mda/docs/p040021.html

-- Total Temporomandibular Joint Replacement System

Intended use: as a total jaw replacement due to conditions that include fused joints, severe fractures, and tumors

http://www.fda.gov/cdrh/mda/docs/p040021.html

-- PAXgene Blood RNA System

Intended use: to collect blood samples and isolate RNA for diagnostic tests

http://www.fda.gov/cdrh/mda/docs/k042613.html

 

To view an archive of past FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

 

BioMerieux Inc.'s VeriCal Calibrator Sets (for monitoring anticoagulation therapy)

Reason for recall: mislabeling that could lead to serious adverse effects, including death

http://www.fda.gov/oc/po/firmrecalls/biomerieux10_05.html

 

Certain lots of Little Michael Dried Apricots; 11-oz. clear plastic containers

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/aurora10_05.html

 

Certain lots of Fortuna Sea Products' frozen cooked clam meat; 1-lb. size

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/fortuna10_05.html

 

Henretty's World Famous Jumbo Crab Cakes

Reason for recall: undeclared eggs

http://www.fda.gov/oc/po/firmrecalls/henretty10_05.html

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

 

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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UPCOMING PUBLIC MEETINGS

 

Oct. 20 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Under discussion: pediatric oncology drugs

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d102005.html

 

Oct. 20-21 -- Nonprescription Drugs Advisory Committee

Under discussion: the benefits and risks of antiseptic products marketed for consumers

Location: Silver Spring, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12541dd10202105.html

 

Oct. 25-26 -- Advisory Committee for Pharmaceutical Science

Under discussion: Quality-by-Design topics, including drug release or dissolution specifications

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12539dd10252605.html

 

Oct. 25-26 -- Psychopharmacologic Drugs Advisory Committee

Under discussion: the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12544dd10252605.html

 

Dec. 7-8 -- Hearing to obtain public input on the agency's current risk communications and outreach strategies, which include patient information sheets, press releases, public health advisories, and other tools.

Location: Washington, D.C.

http://www.fda.gov/bbs/topics/answers/2005/ans01367.html

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

 

 

QUESTION OF THE WEEK

What is cardiovascular disease?Cardiovascular disease (CVD) is not one single disease or condition. It is a group of different disorders that affect your heart and blood vessels. Some types of CVD occur from birth, and others are developed over a lifetime.To learn more about specific cardiovascular conditions and diseases go to the following links:

-- Angina (chest pain)

http://www.fda.gov/hearthealth/conditions/angina.html

-- Atherosclerosis (hardening of the arteries)

http://www.fda.gov/hearthealth/conditions/atherosclerosis.html

-- Congestive heart failure

http://www.fda.gov/hearthealth/conditions/congestiveheartfailure.html

-- Coronary artery disease

http://www.fda.gov/hearthealth/conditions/coronaryarterydisease.html

-- Heart attack

http://www.fda.gov/hearthealth/conditions/heartattack.html