June 25, 2008

Update on the Outbreak

June 25, 2008: At this time, FDA recommends consuming raw red plum, raw red Roma, or raw red round tomatoes only if grown and harvested from the following areas that HAVE NOT BEEN ASSOCIATED WITH THE OUTBREAK:
• Alabama
• Alaska
• Arkansas
• California
• Colorado
• Connecticut
• Delaware
• Florida (counties of: Jackson, Gadsden, Leon, Jefferson, Madison, Suwannee, Hamilton, Hillsborough, Polk, Manatee, Hardee, DeSoto, Sarasota, Highlands, Pasco, Sumter, Citrus, Hernando, Charlotte)*
• Georgia
• Hawaii
• Illinois
• Indiana
• Iowa
• Kansas
• Kentucky
• Louisiana
• Maine
• Maryland
• Massachusetts
• Michigan
• Minnesota
• Mississippi
• Missouri
• Nebraska
• Nevada New!
• New Hampshire
• New Jersey
• New Mexico
• New York
• North Carolina
• Ohio
• Oklahoma
• Pennsylvania
• South Carolina
• Tennessee
• Texas
• Utah
• Vermont
• Virginia
• Washington
• West Virginia
• Wisconsin
• Belgium
• Canada
• Dominican Republic
• Guatemala
• Israel
• Mexican States (Aguascalientes, Baja California Norte, Baja California Sur, Campeche, Colima, Chiapas, Chihuahua, Distrito Federal, Durango, Guanajuato, Guerrero, Hidalgo, México, Michoacán, Morelos, Nayarit, Nuevo León, Oaxaca, Puebla, Querétaro, Quintana Roo, San Luis Potosí, Sonora, Tobasco, Tamaulipas, Tlaxcala, Veracruz, Yucatán, Zacatecas)
• Netherlands
• Puerto Rico

* Shipments of tomatoes harvested in these counties are acceptable with a certificate issued by the Florida Department of Agriculture and Consumer Services. Consumers who are unsure of here the tomatoes are from that they have in their home are encouraged to contact the store or place of purchase for that information. If consumers are unable to determine the source of the tomatoes, they should not be eaten.

Consumers should also be aware that raw tomatoes are often used in the preparation of fresh salsa, guacamole, and pico de gallo, are part of fillings for tortillas, and are used in other dishes.
Types of tomatoes not linked to any illnesses are cherry tomatoes, grape tomatoes, and tomatoes with the vine still attached.

Since mid April, there have been 652 reported cases of salmonellosis nationwide caused by Salmonella Saintpaul, an uncommon form of Salmonella. At least 71 hospitalizations have been reported. Investigation of Outbreak of Infections Caused by Salmonella Saintpaul (CDC).

June 24, 2008

Recall of Nestlé Pure Life Purified Water


U.S. Food and Drug Administration

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. Recall of Nestlé Pure Life Purified Water

Contact: Nestlé Pure Life 866-599-8980

FOR IMMEDIATE RELEASE -- (GREENWICH, Connecticut, June 24, 2008) – This announces a product recall for the one-gallon Nestlé Pure Life Purified Drinking Water sold ONLY in hop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size.

Fewer than 150 one-gallon bottles of Nestlé Pure Life Purified Water are implicated, produced in short timeframe on May 5, 2008 between 8:00 AM and 9:00 AM. The product date code is printed on the shoulder of one-gallon bottles. The code is:

First line…………050508126WF024
Second line……... Starts with the numbers "08"
For example: 0801BB05/2010

The product in question may contain a diluted form of a common food grade cleaning compound that results in a bitter or sour taste. This could pose a potential health concern if ingested in large quantities over an extended period of time and should not be consumed or used in preparing infant formulas or other foods or beverages. No illnesses have been reported.
To further assure consumers, Shop-Rite, as of Monday, June 23rd, has removed any remaining affected product from their stores and warehouses.

Consumers who possess this product or have questions should contact the company at a toll free number 866-599-8980 available 24 hours a day. This same toll-free number is also printed on the front of all product labels for the one-gallon size.

Recall Bulletin

June 23, 2008

Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk

Contact:
Fresca Italia, Inc
415-468-9800

FOR IMMEDIATE RELEASE -- June 23, 2008 -- Fresca Italia of Brisbane, CA is recalling
Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

This product was distributed in the San Francisco Bay Area and Southern California in retail stores and restaurants. This product weighs approximately 8.8oz and is packaged in a white and green plastic wrapper with the manufacturer’s name, "Caseificio Voglie di Latte" and the product name "Burrata." ALL LOT CODES AND EXPIRATION DATES from this manufacturer are subject to recall. Previously, the only batch subject to the recall will be labeled with the expiration date of 24/5/2008. The following quantities were distributed:

• 606 lbs with the Lot Code 24/5/2008
• 661 lbs with the Lot Code 31/5/2008
• 490 lbs with the Lot Code 07/06/2008

The recall is the result of survey sampling by the California Dept. of Food & Agriculture which revealed that the product in question contained the bacteria. Fresca Italia has immediately halted further distribution. This recall is an expansion of the previous recall initiated on May 30, 2008. Positive results for Listeria were found in other lots of the product by the Food and Drug Administration.

If you have any Caseificio Voglie di Latte Burrata with an expiration of 24/5/2008 please return it to the place of purchase for a full refund. Consumers with questions may contact the company at 415-468-9800.

June 23, 2008

Expands Recall of Burrata Cheese Because of Possible Health Risk

U.S. Food and Drug Administration

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. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk

Contact: Fresca Italia, Inc 415-468-9800

FOR IMMEDIATE RELEASE -- June 23, 2008 -- Fresca Italia of Brisbane, CA is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
This product was distributed in the San Francisco Bay Area and Southern California in retail stores and restaurants.

This product weighs approximately 8.8oz and is packaged in a white and green plastic wrapper with the manufacturer’s name, "Caseificio Voglie di Latte" and the product name "Burrata." ALL LOT CODES AND EXPIRATION DATES from this manufacturer are subject to recall. Previously, the only batch subject to the recall will be labeled with the expiration date of 24/5/2008. The following quantities were distributed:

* 606 lbs with the Lot Code 24/5/2008
* 661 lbs with the Lot Code 31/5/2008
* 490 lbs with the Lot Code 07/06/2008

The recall is the result of survey sampling by the California Dept. of Food & Agriculture which revealed that the product in question contained the bacteria. Fresca Italia has immediately halted further distribution. This recall is an expansion of the previous recall initiated on May 30, 2008. Positive results for Listeria were found in other lots of the product by the Food and Drug Administration.

If you have any Caseificio Voglie di Latte Burrata with an expiration of 24/5/2008 please return it to the place of purchase for a full refund. Consumers with questions may contact the company at 415-468-9800.

June 20, 2008

Update on the Investigation, June 20, 2008

The FDA has completed the traceback for some of the tomatoes associated with the salmonella outbreak. The agency has been able to trace the pathway of some tomatoes from the point of purchase (e.g. supermarket) or consumption (e.g. restaurant) to each point on the distribution chain down to certain farms in Mexico and Florida.

The FDA is now working to narrow the investigation. As part of this, the agency is sending teams of multi-disciplinary experts to both Mexico and Florida this weekend to conduct joint inspections of the farms and other critical points on the supply chain where the tomatoes may have become contaminated.

The FDA investigators will conduct joint inspections with regulators in Mexico and Florida at the farms and other distribution points. Meanwhile, the FDA will continue to collect samples of tomatoes and conduct traceback activities.

To further narrow the investigation, the FDA is working with the state of Texas to traceback a cluster of illnesses recently found by the state of Texas. We are hopeful that this will provide additional information to bring the agency closer to the source of the contamination.

The FDA is working jointly with Mexico and Florida and other states to update the list of areas not associated with the outbreak and will continue to post the information on the web site. Raw red plum, red Roma, and red round tomatoes, harvested from one of the sources that FDA has identified below are NOT associated with the outbreak and are acceptable to eat. Cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, from all sources, and tomatoes grown at home are also not linked to the outbreak and can be eaten.

June 19, 2008

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Requests Seizure of Animal Food Products at PETCO Distribution Center

Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.

U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term "insanitary" to describe such conditions).

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

"We simply will not allow a company to store foods under filthy and unsanitary conditions that occur as a direct result of the company's failure to adequately control and prevent pests in its facility," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "Consumers expect that such safeguards will be in place not only for human food, but for pet food as well."

The distribution center in Joliet, Ill., provides pet food products and supplies to PETCO retail stores in 16 states including Alabama, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin.

FDA has no reports of pet illness or death associated with consumption of animal food distributed by PETCO, and does not have evidence that the food is unsafe for animals. However, the seized products were in permeable packages and held under conditions that could affect the food's integrity and quality.

As a precaution, consumers who have handled products originating from the PETCO distribution center should thoroughly wash their hands with hot water and soap. Any surfaces that came in contact with the packages should be washed as well. Consumers are further advised as a precaution to thoroughly wash products sold in cans and glass containers from PETCO in the 16 affected states.

If a pet has become ill after eating these food products, pet owners should contact their veterinarian and report illnesses to FDA state consumer complaint coordinators.

June 9, 2008

ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets

Contact:
Ann McBride
1-800-321-1705

FOR IMMEDIATE RELEASE -- St. Louis, MO – June 9, 2008 – ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness.

Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.

The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with "60" on one side, and "E" on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA). Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website. at

June 6, 2008

Lake Country® Lamb Feed Voluntary Recall

Contact: Lydia Botham, 651-481-2123
Dave Karpinski, 651-481-2360

FOR IMMEDIATE RELEASE -- St. Paul, Minn -- June 6, 2008 -- The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper.

The products and lot numbers involved in the recall were produced at the Fremont, Neb., feed plant only, and are described as:

LC59 1311317 Lake Country® Honor Show Lamb Grower DX Pellet
LD51 1311319 Lake Country® Honor Show Lamb Starter DX Pellet

Lot numbers range from Jan. 1, 2008, to May 30, 2008, and are listed on the bag as 8JAN01FRE1 to 8MAY30FRE1 inclusive.

Lot numbers are printed on both the tag and sewing strip of each bag. Lot numbers are formatted as follows: Example 8MAY30FRE1 – 8=Year / MAY= Month / 30=Day of Month / FRE1=Plant Code.

The products included in this recall were distributed only in the following areas: Nebraska, north central Kansas, northwest Colorado, southern Minnesota, and western and south central Iowa.

The recall was initiated after receiving a customer complaint regarding the products. In addition, Land O'Lakes Purina Feed stopped producing the lamb feeds at the Fremont, Neb. plant and immediately began product testing.

To date, the presence of copper above acceptable levels has been found, which can cause serious health issues, and at high levels, mortality in sheep.

Retailers have been contacted to quarantine these products and notify customers who purchased the product. The affected product should not continue to be stored or used.

Customers who purchased these products will receive replacement product.

For more information on the product recall, contact Customer Service at 1-877- 585-2365.

June 6, 2008

Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax® Multivitamin

Contact:
Leiner Health Products Consumer Relations
(800) 533-8482

FOR IMMEDIATE RELEASE -- Carson, CA -- June 6, 2008 -- Leiner Health Products Inc. ("Leiner" or "the Company") today announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Liquimax Multivitamin was distributed nationwide in retail stores.

The Company has been made aware of the presence of these allergens after receiving consumer reports of an allergic reaction. The Company is aggressively investigating the situation, and currently believes a certain number of bottles of the product contain the listed allergens. Further, the Company has consulted with the U.S. Food and Drug Administration (the "FDA") and the agency is aware of the Company's actions.

Consumers allergic to the above listed allergens are advised not to consume the product and are asked to call 1-800-533-8482 for a full refund. This number can be contacted 24 hours a day with representatives available Monday through Friday between the hours of 8 am and 5 pm (EDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:

Regular Mail: use postage-paid FDA form 3500 available here:

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

June 4, 2008

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are salmonella serotype Saintpaul, an uncommon type of Salmonella.

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The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience
fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses.

Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

From April 23 though June 1, 2008, there have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico and Texas, including 17 hospitalizations.

Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes.

There are no reported deaths.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available, FDA will update this warning.

Last year FDA began a multi-year Tomato Safety Initiative to reduce the incidence of tomato-related foodborne illness. The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.

A key element of the Food Protection Plan -- a scientific and a risk-based approach to strengthen and protect the nation's food supply—is prevention. FDA encourages producers to critically reexamine their operations and apply the scientific principles and regulations established decades ago to provide a safe product for the consumer.

Information on safe handling of produce can be found at here.

Tomato consumer page has more information.
Updates from the Centers for Disease Control and Prevention can be found at on the CDC website.

May 30, 2008

Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk

Contact:
Fresca Italia, Inc.
415-468-9800

FOR IMMEDIATE RELEASE -- May 30, 2008 -- Fresca Italia of Brisbane, CA is recalling Burrata because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

This product was distributed in the San Francisco Bay Area and Southern California in retail stores and restaurants.

This product weighs approximately 8.8oz and is packaged in a white and green plastic wrapper with the manufacturer’s name, “Caseificio Voglie di Latte” and the product name “Burrata” The only batch subject to the recall will be labeled with the expiration date of 24/5/2008.

The recall is the result of survey sampling by the California Dept. of Food & Agriculture which revealed that the product in question contained the bacteria. Fresca Italia has immediately halted further distribution.

If you have any Caseificio Voglie di Latte Burrata with an expiration of 24/5/2008 please return it to the place of purchase for a full refund. Consumers with questions may contact the company at 415-468-9800.

May 30, 2008

Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans

Contact:
Consumer Hotline
(800) 638-6493

FOR IMMEDIATE RELEASE -- May 30, 2008 -- Abbott today announced a voluntary worldwide recall of two lots of Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD® is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order.

Abbott is voluntarily recalling two lots of product because small amounts of air may have entered the can, resulting in product oxidation. A common sign of oxidation is an off aroma. The problem is isolated to these two lots of Calcilo XD Powder in 14.1-ounce (400g) cans.

Consumption of highly oxidized foods can cause gastrointestinal (GI) symptoms such as nausea, vomiting and diarrhea. If parents have questions or concerns they should contact a health care professional.

The recall is limited to Calcilo XD in 14.1-ounce (400g) cans, with stock code number 00378 and with lot numbers 39973RB or 47239RB6 printed on the bottom of the cans. No other Calcilo XD powdered infant formulas are affected.

The two lots were distributed in the United States, Canada, Malaysia, Korea and Bahrain, between 06/06/06 and 04/17/08. Consumers who purchased Calcilo XD® Low-Calcium/Vitamin D-Free Infant Formula with Iron powder from either of the two lots mentioned above should contact Abbott Nutrition at 1-800-638-6493.

Abbott is working with its distribution partners and the U.S. Food and Drug Administration to execute this recall.

May 15, 2008

Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese

Contact:
John Harrison
Sweetwater Valley Farm, Inc.
877-862-4332

FOR IMMEDIATE RELEASE -- May 15, 2008 -- Sweetwater Valley Farm, Inc. of Philadelphia, TN is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

sweetwater1.jpg

Tennessee Aged Black Pepper Cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN.

Less than 100 pounds was distributed.

This product was distributed between December 27, 2007 and May 12, 2008.

No illnesses have been reported.

The recall was the result of a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the bacteria. The company has ceased the distribution of this lot as the company continues their investigation as to what caused the problem.

Consumers who have purchased lot number 616-361 of this product are urged bring it to the store for replacement or refund or ship it back to the store for replacement or refund. Contact the
company’s consumer affairs department at 1-877-862-4332 for further information.

May 15, 2008

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass

Contact:
Daniel Beach
Public Relations
763-505-2603

FOR IMMEDIATE RELEASE -- MINNEAPOLIS – May 7, 2008 – Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.

Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.

Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has initiated a precautionary recall of affected Carmeda products.

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic's ultimate goal is to remove contaminated products from the market. However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.

The above actions are being made with the knowledge of the U.S. Food and Drug Administration.

Patients with questions should talk to their physician. Physicians or Pefusionists with medical questions related to Medtronic therapies should contact Medtronic at 1-800-638-0218, Monday -
Friday, 8:00 a.m. to 5:00 p.m. CDT.

April 28, 2008

Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff® Villa della Luna® pattern and Nautica J Class® pattern (Red Only) Stoneware Dinnerware Product Lines

Contact:
(800) 499-1976 – For Pfaltzgraff® Dinnerware
(866) 928-0060 – For Nautica® Dinnerware

FOR IMMEDIATE RELEASE -- April 28, 2008 -- Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff® Villa della Luna® pattern and Nautica J Class® pattern stoneware dinnerware products may exceed the Food and Drug Administration’s (“FDA”) guidance levels for lead and/or cadmium. No illness related to these products has been reported to date.

Specifically, the following products are subject to this recall:

Nautica J Class® Red Dinner Plates Villa della Luna® Dinner Plates
Nautica J Class® Red Salad Plates Villa della Luna® Soup/Cereal Bowls

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lifetime_nauticasalad.jpg

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These dinnerware products may have been sold as part of a set or individually online and through retail stores nationwide.

For additional information regarding the recall, please contact us by dialing the following toll free
numbers:
(800) 499-1976 – For Pfaltzgraff® Dinnerware
(866) 928-0060 – For Nautica® Dinnerware