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Shoulder Massager, Prenatal Supplements Recalled for Safety, Allergy Hazards

RECALLshoulderflexmassageA popular massager and prenatal supplements are the subject of recall today.

 

 

Shoulderflex Massager

In cooperation with the Food and Drug Administration (FDA), King International LLC Is initiating a recall of the Shoulderflex massager due to a report of a strangulation and death. Consumers, retailers and catalog sellers are being advised to immediately stop using Shoulderflex massagers, and to safely dispose of them in the trash.


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This announcement relates to all of the approximately 12,000 Shouderflex massagers which were sold between 2003 and 2011. The devices were sold at various stores (including Relax the Back), in catalogs (including Lifestyle Fascination), and online retailers (including Amazon) in the United States.

King International advises that the device components be disposed of separately so that the massager cannot be reassembled and used. The most effective way to do that is to dispose of the power supply separate from the massager unit, and to remove the massage fingers and dispose of them separately.

This is a voluntary recall program conducted by King International as part of its commitment to safety. There has been a report of a strangulation and death. There was a warning never to wear a necklace to avoid entanglement. King International shares FDA’s desire to take prompt action to reduce the risk of injury. Accordingly, King International asks customers to immediately stop using Shoulderflex massagers and to safely dispose of them in the trash, and for retailers and catalog sellers to take similar action.

Additional information about this recall campaign can be obtained from King International LLC at (503) 524-7046, through its website (www.shoulderflex.com) or by writing to King International at PO Box 2384, Beaverton, OR 97075.

RECALLPrenatalnutrientsPrenatal Supplements

Pure Encapsulations of Sudbury, Massachusetts is voluntarily recalling PreNatal Nutrients lot number 3560111, because it may contain undeclared egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

PreNatal Nutrients is available as two-piece hard capsules in white HDPE plastic bottles in both 120 count (product code PRE12) as well as 60 count (PRE6) under the brand name Pure Encapsulations. The lot number and best by date are 3560111A or 3560111B best by date 01/13.

PreNatal Nutrients was distributed nationwide through healthcare practitioners.

One report of an allergic reaction in an individual has been confirmed to date.

The recall was initiated after a physician customer reported an allergic reaction by one of their patients. Immediately upon receipt of this report, Pure Encapsulations sent retention samples to an independent, 3rd party laboratory for testing of the top eight allergens. Results indicated the presence of egg allergen.

Pure Encapsulations has on file Allergen Statements from each supplier of each of the ingredients used in the batch of this formulation. All Allergen Statements indicate that the ingredients do not contain any of the 8 major allergens including egg. Pure Encapsulations has sent reserve samples of each of the lots of the ingredients used in this batch, in addition to the empty capsules, for testing to determine which ingredient caused the positive result for egg allergen.

Consumers who have purchased Pure Encapsulations PreNatal Nutrients are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Mr. Jean Gagnon, Vice President of Operations, at 1-800-753-2277 x335. Monday through Friday between 9:00 am – 5:00 pm.