From:
Sukie Crandall
Date: 2007-04-19 19:37:02 UTC
Subject: [ferrethealth] press releases recalls info (medical devices, rice protein concentrate)
To: ferrethealth@yahoogroups.com, ferret-l@LISTSERV.FERRETMAILINGLIST.ORG
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=20
Significant Manufacturing Violations
U.S. Food and Drug Administration (FDA) investigators and U.S.=20
Marshals today seized all implantable medical devices from Shelhigh,=20
Inc., Union, N.J., after finding significant deficiencies in the=20
company's manufacturing processes. The deficiencies may compromise=20
the safety and effectiveness of the products, particularly their=20
sterility.
The products include pediatric heart valves and conduits (tube-like=20
devices for blood flow), surgical patches, dural patches (to aid in=20
tissue recovery after neurosurgery), annuloplasty rings (to help=20
repair heart valves) and arterial grafts. The tissue-based devices=20
are used in many surgical settings, including open heart surgery in=20
adults, children and infants, and to repair soft tissue during=20
neurosurgery and abdominal, pelvic and thoracic surgery. Critically=20
ill patients, pediatric patients and immuno-compromised patients may=20
be at greatest risk from the use of these devices.
All medical device companies must follow current good manufacturing=20
practice, a set of requirements that help to ensure the safety and=20
effectiveness of all medical products. Shelhigh's violations include:=20
manufacturing products in a facility with a poorly constructed and=20
poorly maintained clean room where sterilized devices are further=20
processed; failing to adequately monitor critical manufacturing=20
environments for possible microbial contamination; failing to=20
properly test products for sterility and fever-causing contaminants;=20
and failing to scientifically support product expiration dates.
Physicians should consider using alternative devices. Physicians=20
should also monitor patients with a Shelhigh implant for infections=20
and proper device functioning over the expected lifetime of the=20
device. Patients who think they may have received a Shelhigh device=20
during surgery should contact their physician for more information.=20
FDA will issue a Preliminary Public Health Notification to physicians=20
and other health care professionals and a Preliminary Advice for=20
Patients shortly with more information; those documents will be=20
posted to FDA's Web site.
The seizure follows an FDA inspection of the Shelhigh manufacturing=20
facility last fall, as well as meetings with the company at which FDA=20
warned Shelhigh that failure to correct its violations could result=20
in an enforcement action. FDA also alerted the company to its=20
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=20
contaminated bag received by the importer, that bag was of a=20
different color, and that bag clearly stated that the contents=20
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=20
withdrawals from the firms involved as a service to consumers, the=20
media, and other interested parties. FDA does not endorse either the=20
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 --=20
Wilbur-Ellis Company is voluntarily recalling all lots of the rice=20
protein concentrate the San Francisco company=92s Feed Division has=20
shipped to pet-food manufacturers because of a risk that rice protein=20
concentrate may have been contaminated by melamine, an industrial=20
chemical used to make plastics and fertilizers that can lead to=20
illness or fatalities in animals if consumed.
Wilbur-Ellis noted that it obtained rice protein from a single source=20
in China and shipped to a total of five U.S. pet-food manufacturers=20
located in Utah, N.Y., Kansas and two in Missouri.
Last Sunday, April 15, Wilbur-Ellis notified the U.S. Food and Drug=20
Administration that a single bag in a recent shipment of rice protein=20
concentrate from its Chinese supplier, Binzhou Futian Biology=20
Technology Co. Ltd., had tested positive for melamine. Unlike the=20
other white-colored bags in that shipment, the bag in question was=20
pink and had the word =93melamine=94 stenciled upon it. Wilbur-Ellis=20
separated that bag and quarantined the entire shipment for further=20
testing and since that time, no further deliveries of rice protein=20
concentrate have been made. Samples from the white bags tested=20
negative for melamine. However, subsequent and potentially more=20
sensitive tests by the FDA came back positive for melamine, leading=20
Wilbur-Ellis to voluntarily issue the recall.
Wilbur-Ellis began importing rice protein concentrate from Binzhou=20
Futian Biology Technology in July 2006. A total of 14 containers=20
holding 336 metric tons of rice protein concentrate were sent from=20
Futian to Wilbur-Ellis. Wilbur-Ellis has distributed 155 metric tons=20
to date.
On Monday (April 16), a pet food distributor issued a voluntary=20
recall of its pet food, believing the source of contamination to be=20
rice protein concentrate supplied by Wilbur-Ellis. As an additional=20
precaution, Wilbur-Ellis is urging all pet food manufacturers using=20
rice protein concentrate supplied through Wilbur-Ellis to recall any=20
pet food that may be on supermarket shelves.
Consumers with questions about the pet food they use should visit the=20
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
Sukie (not a vet)
Current FHL address:
http://groups.yahoo.com/group/ferrethealth
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
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