[FHL crosspost]

Not knowing if any vets use these devices:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01612.html

BEGIN QUOTE
FDA News
FOR IMMEDIATE RELEASE
P07-69
April 17, 2007

Media Inquiries:
Heidi Rebello, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Seizes All Medical Products From N.J. Device Manufacturer for
Significant Manufacturing Violations

U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals
today seized all implantable medical devices from Shelhigh, Inc.,
Union, N.J., after finding significant deficiencies in the company's
manufacturing processes. The deficiencies may compromise the safety
and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like
devices for blood flow), surgical patches, dural patches (to aid in
tissue recovery after neurosurgery), annuloplasty rings (to help repair
heart valves) and arterial grafts. The tissue-based devices are used
in many surgical settings, including open heart surgery in adults,
children and infants, and to repair soft tissue during neurosurgery
and abdominal, pelvic and thoracic surgery. Critically ill patients,
pediatric patients and immuno-compromised patients may be at greatest
risk from the use of these devices.

All medical device companies must follow current good manufacturing
practice, a set of requirements that help to ensure the safety and
effectiveness of all medical products. Shelhigh's violations include:
manufacturing products in a facility with a poorly constructed and
poorly maintained clean room where sterilized devices are further
processed; failing to adequately monitor critical manufacturing
environments for possible microbial contamination; failing to properly
test products for sterility and fever-causing contaminants; and failing
to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should
also monitor patients with a Shelhigh implant for infections and proper
device functioning over the expected lifetime of the device. Patients
who think they may have received a Shelhigh device during surgery
should contact their physician for more information. FDA will issue a
Preliminary Public Health Notification to physicians and other health
care professionals and a Preliminary Advice for Patients shortly with
more information; those documents will be posted to FDA's Web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing
facility last fall, as well as meetings with the company at which FDA
warned Shelhigh that failure to correct its violations could result
in an enforcement action. FDA also alerted the company to its
manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

Shelhigh Pericardial Patch
Shelhigh No-React Pericardial Patch
Shelhigh No-React PneumoPledgets
Shelhigh No-React VascuPatch
Shelhigh No-React Tissue Repair Patch/UroPatch
Shelhigh Pulmonic Valve Conduit No-React Treated
Shelhigh No-React Dura Shield
Shelhigh BioRing (annuloplasty ring)
Shelhigh No-React EnCuff Patch
Shelhigh No-React Stentless Valve Conduit
Shelhigh Internal Mammary Artery
Shelhigh Gold perforated patches
Shelhigh Pre Curved Aortic Patch (Open)
Shelhigh NR2000 SemiStented aortic tricuspid valve
Shelhigh BioConduit stentless valve
Shelhigh NR900A tricuspid valve
Shelhigh MitroFast Mitral Valve Repair System
Shelhigh BioMitral tricuspid valve
Shelhigh Injectable Pulmonic Valve System
END QUOTE

In the case of the rice protein concentrate there was ONE contaminated
bag received by the importer, that bag was of a different color, and
that bag clearly stated that the contents included melamine.
http://www.fda.gov/oc/po/firmrecalls/wilburellis04_07.html

BEGIN QUOTE
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market
withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the
product or the company.

Wilbur-Ellis Voluntarily Recalls Rice Protein Concentrate

Contact:
Ann Barlow
415-438-9826; 925-200-6539
Deborah Brown
212-931-6113

FOR IMMEDIATE RELEASE -- San Francisco, CA -- April 18, 2007 --
Wilbur-Ellis Company is voluntarily recalling all lots of the rice
protein concentrate the San Francisco company's Feed Division has
shipped to pet-food manufacturers because of a risk that rice protein
concentrate may have been contaminated by melamine, an industrial
chemical used to make plastics and fertilizers that can lead to illness
or fatalities in animals if consumed.

Wilbur-Ellis noted that it obtained rice protein from a single source
in China and shipped to a total of five U.S. pet-food manufacturers
located in Utah, N.Y., Kansas and two in Missouri.

Last Sunday, April 15, Wilbur-Ellis notified the U.S. Food and Drug
Administration that a single bag in a recent shipment of rice protein
concentrate from its Chinese supplier, Binzhou Futian Biology
Technology Co. Ltd., had tested positive for melamine. Unlike the other
white-colored bags in that shipment, the bag in question was pink and
had the word "melamine" stenciled upon it. Wilbur-Ellis separated that
bag and quarantined the entire shipment for further testing and since
that time, no further deliveries of rice protein concentrate have been
made. Samples from the white bags tested negative for melamine.
However, subsequent and potentially more sensitive tests by the FDA
came back positive for melamine, leading Wilbur-Ellis to voluntarily
issue the recall.

Wilbur-Ellis began importing rice protein concentrate from Binzhou
Futian Biology Technology in July 2006. A total of 14 containers
holding 336 metric tons of rice protein concentrate were sent from
Futian to Wilbur-Ellis. Wilbur-Ellis has distributed 155 metric tons
to date.

On Monday (April 16), a pet food distributor issued a voluntary recall
of its pet food, believing the source of contamination to be rice
protein concentrate supplied by Wilbur-Ellis. As an additional
precaution, Wilbur-Ellis is urging all pet food manufacturers using
rice protein concentrate supplied through Wilbur-Ellis to recall any
pet food that may be on supermarket shelves.

Consumers with questions about the pet food they use should visit the
FDA Web site at www.fda.gov.

END QUOTE

Further info on RECALLS OF MANY TYPES:
http://www.fda.gov/opacom/7alerts.html

PILOT PROJECT TO HELP ALERT PEOPLE TO RECALLS:
http://www.fda.gov/oc/po/firmrecalls/pilot.html

Sukie (not a vet)
Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/fhc/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html

[Posted in FML 5583]