[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]