Tag Archives: National

Medical advisory on St. Jude Optisure dual coil defibrillation leads for implantable cardioverter defibrillators

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St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step. The company has received no reports of lead malfunction or patient injury related to this issue and all physicians with patients impacted by this advisory have been notified.

Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators (ICDs), which monitor the heartbeat of patients suffering from heart rhythm disorders. An ICD’s leads deliver electric current to the heart to help restore the heart to its normal rhythm when needed.

On November 3, 2015, St. Jude Medical began the global process of notifying physicians following patients who have been implanted with the 447 Optisure dual coil leads subject to this advisory. An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava (SVC) shock coil in a limited and well-defined group of Optisure leads could result in cuts to the insulation of the lead. Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high voltage therapy.

A St. Jude Medical internal investigation found the probability that a lead was damaged as a result of the manufacturing variation to an extent that it could result in the inability to deliver appropriate high voltage therapy is very low and that any associated risks can be prevented with device reprogramming. The patients’ leads can also be monitored from home using the Merlin.net™ remote care system. The company has not received any reports of compromised performance of the impacted Optisure leads. St. Jude Medical is in the process of providing an updated advisory notice to physicians to further ensure physicians are aware of recommendations for managing their patients who may have been implanted with the impacted leads.

The advisory notification involves the worldwide distribution of 447 Optisure dual coil defibrillation leads manufactured and distributed by St. Jude Medical. The advisory relates to units within the following models: LDA220, LDA220Q, LDA230Q, and LDP220Q.

The vast majority of patients implanted with the Optisure leads compromised by the advisory have devices equipped with the St. Jude Medical DynamicTx™ feature that provides additional protection to help ensure delivery of appropriate high voltage therapy even in the case of a compromised lead. For these patients, physicians are advised to enroll patients in the Merlin.net patient care network, ensure the DynamicTx feature is programmed “on” and then monitor patients as per normal follow-up protocols.

Physicians following the 9 patients in the U.S. with compromised leads not connected to a device with the DynamicTx feature have been advised to enroll these patients in the Merlin.net patient care network and, where appropriate, consider turning off the SVC coil. If a dual coil shocking configuration is desired, physicians should consider performing a high voltage test when clinically appropriate to determine whether the lead has been compromised. As of this letter all physicians following the 9 patients have been contacted and provided information about this event.

Patient safety is St. Jude Medical’s highest priority, and the company will continue to work closely with customers and global regulatory agencies to ensure effective communication to our physician partners. The company has alerted all physician customers impacted by the advisory by letter, and all leads subject to this advisory have been accounted for and none remain in any field distribution. The U.S. Food and Drug Administration and other regulatory bodies have been notified. For more information, patients or their physicians can visit www.sjm.com/optisureadvisorydisclaimer icon or call the St. Jude Medical customer service team 24 hours a day at (800) 328-9634.

Whole Foods Recalls Frozen Pizza Products Due to Misbranding

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Whole Foods/North Atlantic Kitchens, an Everett, Mass. establishment, is recalling approximately 73,898 pounds of pepperoni pizza products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product is labeled as containing uncured beef pepperoni. However, the pizzas contain uncured pork pepperoni, which is not declared on the product label. Some individuals have a sensitivity or intolerance to pork.

The fresh pizza items were produced Jan. 5, 2015, through Jan. 22, 2016.
pizza

  • 10-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 8”.
  • 19-oz. vacuum-sealed packages of “WHOLE FOODS MARKETS, PIZZA, PEPPERONI, 12”.

The products subject to recall bear establishment number “EST. 20234” inside the USDA mark of inspection and Sell-by dates of Jan. 12, 2015 through Jan. 30, 2016 printed on the packaging. These items were shipped for wholesale and retail sale in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, and Rhode Island.

The problem was discovered by FSIS during a label review at the establishment and occurred as a result of a change in ingredient suppliers.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Berks Packing Co. Recalls Beef Products Due to Misbranding

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Berks Packing Co., a Reading, Pa. establishment, is recalling approximately 1,320 pounds of beef products that may be misbranded, and may contain pork and erythorbate, an additive, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The beef knockwurst links were produced on Nov. 12, 2015.
Berks-2

Berks-1
>> 1-lb. (plastic shrink wrapped) packages containing links of “BERKS Heat & Serve Knockwurst.” The packages have a sell by date of March 11, 2016 printed on the package.

The products subject to recall bear establishment number “EST. 8782” inside the USDA mark of inspection. These items were shipped to retail locations in Pennsylvania, New Jersey, Maryland, New York, West Virginia, Virginia, and Delaware.

The problem was discovered by company personnel who learned of the incorrect labels being applied to the product and notified FSIS inspectors.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Mars Chocolate recalls DOVE® Chocolate Assortment Snowflakes

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Dove-3Mars Chocolate North America Issues Allergy Alert Voluntary Recall on Undeclared Peanuts, Wheat and Egg Ingredient for DOVE® Chocolate Assortment Snowflakes, 24.0 oz. Bag, Sold Only at One Major Retailer with Stores Across the U.S.

Today, Mars Chocolate North America announced a voluntary recall of its DOVE® Chocolate Assortment Snowflakes, 24.0 oz. bag – this is a seasonal item only sold at one major retailer with stores across the U.S.

Item# 10139802 – UPC# 400050521
LOT CODE: 537CG4PA30, 537DG4PA30, 538AG4PA30, 538AM4PA30, 541AG4PA20, 542EM4PA20

This item is a purple 24 oz. bag clearly marked with DOVE® Chocolate Assortment Snowflakes branding on the front of packaging. The code dates and UPC code are located on the back of the packaging on the lower right side.

Approximately 6,700 cases of this item may contain some SNICKERS®, MILKY WAY® and TWIX® pieces that contain peanuts, wheat and/or eggs, but these ingredients are not listed on the outer package ingredient label. People who have allergies to peanuts, wheat and/or eggs have the risk of serious or life-threatening allergic reaction if they consume these products. No adverse reactions have been reported to date.

This item was shipped and distributed to only one retailer and sold at retail food stores starting September 19, 2015 through December 1, 2015 to the following locations: AZ, GA, MA, MS, OH, VA, CA, IA, MD, NH, OK, VT, CO, IL, ME, NJ, OR, WA, CT, IN, MI, NM, PA, WI, DE, KS, MN, NV, RI, WY, FL, KY, MO, NY and TX.

The issue was identified after a consumer notified Mars Chocolate North America of finding a SNICKERS® piece in this Dove Chocolate Assortment Snowflakes, 24.0 oz. bag.

Mars Chocolate is working with the impacted retailer to ensure that the recalled product is removed from sale. In the event that consumers believe they have purchased this item and have allergy concerns, they should return this product to the store where they purchased it for a full refund. Consumers with questions or concerns may call our toll-free number at 1-800-551-0907.

SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo

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Dallas, TX, SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it.

Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or info@smartlipo365.com on Monday through Friday from 10 A.M. to 5 P.M. (Central time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

ARRL sponsors Rookie Roundup

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ARRL-Flag-waving-Large_54The American Amateur Radio Relay League (ARRL) is sponsoring a six-hour CW (Morse code) contest on December 20 for specifically aimed at those who have had a license less than three years. (So you were proud of yourself for getting your Amateur Extra only to learn you are a rookie for three years.)

ARRL sponsors Rookie contests three times a year in April, August and December. In these contests rookies can contact anyone, but old-timers can only contact rookies. Various contests are held by ARRL and other organizations throughout the year. These for rookies are particularly useful to learn how to use the frequencies for the new license levels they attain. It is a great opportunity to test new equipment. Additionally they can obtain awards and certificates for all of these contests.

ARRL also sponsors specific events in addition to contesting where amateur operators can collect special cards, called QSL cards. QSL cards confirm a contact between specific stations or stations to events. ARRL, for example, is sponsoring a year-long event called National Parks on the Air where Ham operators can contact operators stationed at various national parks throughout the country.

For the upcoming CW rookie contest, the ARRL web site states:

Mission: To encourage newly-licensed operators (“Rookies”) in North America (including territories and possessions) to operate on the HF bands and experience competitive Amateur Radio operating. Experienced operators (“Non-Rookies”) are strongly encouraged to participate and help new operators – either on the air or in person.

Objective: Rookies exchange information with as many other stations as possible on the 80, 40, 20, 15, and 10 meter HF bands. Rookie entrants are encouraged to read “HF Contesting – Good Practices, Interpretations and Suggestions.” (Also available as PDF)

Electronic certificates will be emailed to the top five scoring Rookies in each US call area, Canadian province, Mexican call area and DX. No national winners will be recognized. A commemorative participation certificate will be available for download to every Rookie operator submitting a score.

For more information and to sign up, visit the ARRL web site .

State Ousts Leader Of Oregon Amateur Radio Service

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OEMLogo_2014-COLOR_mediumOREGON — The state is cutting ties with the head of Oregon’s amateur radio service, Vince Van Der Hyde.

The cut comes after he asked volunteers not to take part in a recent emergency drill — because of bad equipment and control issues.

When Oregon suffers a major earthquake, cell phones, telephone lines and other communication systems may fail — or be overwhelmed. So the state has an agreement with amateur radio enthusiasts to provide a backup system.

That system was scheduled to be tested during a drill last week.

Read more at Oregon Public Broadcasting

FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

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The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

These actions are part of the FDA’s commitment to patient safety and ongoing efforts to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories. The FDA has been working with federal partners, manufacturers and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.

An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Within seven business days after receiving the FDA’s recall order, Custom Ultrasonics must provide a written recall proposal to the FDA.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”

AERs are Class II medical devices that require 510(k) clearance and are used to wash and high-level disinfect endoscopes to decontaminate them between uses. AERs are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism.
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SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard

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640-472515Campbell Soup Company (NYSE:CPB) is voluntarily recalling 14.2 ounce cans of SpaghettiOs Original due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.

The affected 14.2 ounce SpaghettiOs Original product has a date of February 22, 2017 which is stamped on the base of the can, and a UPC code of 51000 22432 printed under the bar code.

The issue was identified after the company received consumer complaints.

This recall affects 355,000 cans and is limited to the United States.

This product should not be eaten. People who have bought the affected product should return it to the store where it was purchased for an exchange or full refund. For more information call 1-866-535-3774 between 9 a.m. to 7 p.m. EST, Monday to Friday or visit Facebook/SpaghettiOs. Campbell Soup Company apologizes for the inconvenience.

Halo, Purely for Pets® Issues Voluntary Recall of Sensitive Cat Turkey Dry Food Due to Mold

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ucm472417Halo, Purely for Pets has initiated a limited, voluntary recall of its Spot’s Stew Sensitive Cat Turkey kibble with a Best By date of 09/04/2016 due to reports of mold. No other Halo products are affected.

Consumers who have Spot’s Stew Sensitive Cat Turkey stamped “Best By 09/04/2016” should discontinue feeding, and return the remaining portion to any Halo retailer for a full refund or replacement.

While some pets can ingest mold without incident, others may experience digestive issues. Consumers should consult their veterinarian if their cat experiences digestive issues.
Halo is also instructing its retailers to remove Sensitive Cat Turkey products stamped “Best By 09/04/2016” from their shelves.

The affected product is:

Product name:
Spot’s Stew Wholesome Turkey Recipe Sensitive Formula for Cats

UPC Codes:
745158350231 and 745158340232

Sizes:
6 lb. and 3 lb. bags

Best by Date:
09/04/2016

For more information, contact Halo Customer Care at 800-426-4256 Monday-Friday 8:00 a.m. – 5:00 p.m. EST, or email customers@halopets.com or visit www.halopets.comdisclaimer icon.