Showing posts with label alert. Show all posts
Showing posts with label alert. Show all posts

Thursday, 4 February 2010

Alert

Encompass Group Voluntarily Recalls Thermoflect Product Line

Company Contact:
Victoria Young
214-948-5940

FOR IMMEDIATE RELEASE – December 26, 2009 – McDonough, GA – Jea R. Gackowski, Encompass Group Corporate Compliance Officer announced today the company is voluntarily recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment.

"We are voluntarily recalling the product line from use in the Magnetic Resonance (MR) environment," Gackowski said. "We are requesting that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. We are in the process of sending labels to our customers to be attached per instructions to remind the hospitals that the product line should not be used in the MR environment.

"In the past, we have stated that the Thermoflect product may be used in the MR environment. However, after being informed by the FDA, at this time we will not promote the products for use in the Magnetic Resonance Environment. However, the product is still safe and effective for use in treating hypothermia."

We have been advised by the FDA that a report has been filed of an injury to an (MRI) patient. Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one. There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure we are voluntarily recalling the product line for relabeling.

Thermoflect products are distributed nationally and internationally. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

We have concluded that there is currently no ASTM International standard to test Thermoflect in the MR environment, although we have conducted multiple laboratory and field tests. "Until an ASTM standard has been developed by ASTM International, we have removed statements on our website and in our product literature that Thermoflect is MR-Conditional or MR-Compatible.

"In addition to issuing this news release to appropriate magazine and trade paper listings, we have sent letters to our customers, hospitals, and doctors in radiology and will follow up with training and verification surveys."

"At Encompass Group, our mission is always to help healthcare and hospitality providers create safe and comfortable environments for patients, staff, residents and guests. This voluntary recall is another example of our ongoing commitment to those objectives"

For More Information, contact
Jea R. Gackowski, C.H.B., C.C.S.
Corporate Compliance Officer
770-626-2044
Monday – Friday 9 a.m. – 5 p.m. eastern

http://Thermoflect blankets-dobi.blogspot.com/alert

Friday, 29 January 2010

Alert

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.

Whole Foods Market® Recalls Bulk Hazelnuts

Company Contact:
Libba Letton
libba.letton@wholefoods.com
512...

FOR IMMEDIATE RELEASE –- December 19, 2009 - AUSTIN, TX – Whole Foods Market is recalling organic raw hazelnuts (filberts) sold in bulk through its stores in California, Colorado, Kansas, New Mexico, Oregon, Utah and Washington because the nuts were part of a batch that was contaminated with salmonella. The company is also recalling non-organic dry roasted hazelnuts (filberts) sold in bulk through its stores in California, Nevada, Oregon, and Washington, and non-organic raw hazelnuts (filberts) sold in bulk through its stores in Oregon and Washington. These hazelnuts should not be consumed. No illnesses have been reported at this time.

The potential for salmonella contamination was discovered during a routine product sampling at the plant where the hazelnuts were shelled. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Whole Foods Market customers who have purchased the recalled product since Oct. 12 in the states listed above may return the item for a full refund. Consumers with questions may contact the company by calling 512... or by logging on to www.wholefoods.com.

http://organic raw hazelnuts-dobi.blogspot.com/alert

Alert

Evonuk Oregon Hazelnuts Recalls Raw and Dry Roasted Hazelnut Kernels Because of Possible Health Risk

Company Contact:
Shannon Evonuk, Evonuk Oregon Hazelnuts
541-998-1848
Amy Wood, Harvest PR
503-274-0086, ext. 102

FOR IMMEDIATE RELEASE – December 18, 2009 – Evonuk Oregon Hazelnuts of Eugene, OR is recalling 6,712.5 lbs. of raw and dry roasted hazelnut kernels because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

After product sampling, Salmonella was found on one production lot at Willamette Shelling, of Newberg, OR, the facility where Evonuk Oregon Hazelnut’s hazelnuts kernels were shelled. Evonuk Oregon Hazelnuts has decided to recall all raw and dry roasted hazelnut kernels delivered or shipped by Evonuk Oregon Hazelnuts from November 2nd 2009 through December 4th 2009.

Evonuk Oregon Hazelnuts brand raw hazelnut kernels and dry roasted hazelnut kernels subject to recall include:

• Raw hazelnut kernels packed in 25 pound corrugated boxes with lot code numbers 299091A and

296091A.

• Dry roasted hazelnut kernels packed in 25 pound corrugated boxes with lot code numbers 299091A and

296091A.

• 8 ounce, 2.5 pound, and 5 pound packages of raw hazelnut kernels in clear plastic packages, bearing no

lot code. Shipped in corrugated boxes with lot code numbers 299091A and 296091A.

• 4 ounce, 8 ounce, 2.5 pound, and 5 pound packages of dry roasted, salt free, hazelnut kernels in clear

plastic packages, bearing no lot code. Shipped in corrugated boxes with lot code numbers 299091A and 296091A.

These raw and dry roasted products were distributed in retail and wholesale stores, restaurants and bakeries in Washington, Oregon, California, Nevada, Oklahoma and New Jersey. No illnesses have been reported to date.

Consumers who bought the recalled raw and dry roasted hazelnut products are urged to return the product to their place of purchase for a refund. Consumers with questions may contact Shannon Evonuk at (541) 998-1848, Monday through Friday, between 8 a.m. – 5 p.m. PST.