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
___________________________________________________
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.]
___________________________________________________
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.]
___________________________________________________
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
__________________________________________________
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