Monthly Archives: October 2014

Covidien Initiates Voluntary Field Safety Alert for Multi-function Defibrillation Electrodes

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Sample photos from Coviden web site. For illustration only. Contact Coviden for exact models effected by recall.

Sample photos from Coviden web site. For illustration only. Contact Coviden for exact models effected by recall.

Dublin, Ireland — Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.

These electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could result in a delay of therapy. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the compatibility issue until the AED must be used. This may result in a delay in therapy.

Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual.

Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.

Covidien alerted customers to the this issue by letter on September 18, 2014, and has revised labeling to clarify that use of these electrodes is incompatible with Philips FR3 and FRx AED units.

The Field Safety Alert requests that customers review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.

There are a total of 644,460 electrodes affected by this safety alert.

The following Covidien electrodes are affected:

  • 22660R – Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent
  • 22660PC – Medi-Trace™ Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect
  • 20660 – Kendall™ Adult Multi-Function Defibrillation Electrodes
  • 40000006 – Kendall™ 1710H Multi-Function Defibrillation Electrodes

In addition, similar private label electrodes produced by Covidien were also distributed under the following brands, and have the same connector compatibility issue:

  • MC1710H – MediChoice® Multifunction Electrode
  • M3718A – Philips HEARTSTART Multifunction Electrode Pads

The Field Safety Alert applies to all lot numbers distributed globally.

The Food and Drug Administration has classified this as a Class 1 Recall, the most serious recall where there is a reasonable risk of a serious adverse health consequences or death.

For further information or to report a problem, please contact Covidien Quality Assurance at 1-800-962-9888, option 8, then extension 2500 between the hours of 8 a.m. and 5 p.m. (eastern) or email Mansfield.productmonitoring@covidien.com

Want to hold a monster ball? Coke is giving you the chance.

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coke-halloweenDo you want to host a big monster bash on Halloween? Coca-Cola is giving you the opportunity. You will just have to wait until October 2015.

Mycokerewards.com holds regular sweepstakes for those who have set up an account. You enter codes for points to apply toward sweepstakes and other offers.

This year they are repeating their sweepstake for a Halloween party. There is no purchase necessary to enter, but you will have to go to the site and see the rules for entry. The Fanta® MCR Halloween Sweepstakes will be offering three $5000 checks for a great Halloween monster ball. Their ad reads

No tricks. Just a treat. $5000 of wicked fun!

There is, however, one little trick to the sweepstake. The drawing is November 3.

Dimension Industries Recalls Sling Café Sets Due to Fall Hazard

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DimensionTableChairSet640Dimension Industries is recalling about 18,000 sling café sets manufactured by Foshan Shunde Shian Furniture Co Ltd., of China. They were sold exclusively through Costco Wholesale stores nationwide from December 2013 through May 2014 for about $400.

The three-piece sling fabric café sets include two aluminum swivel chairs with medium brown-colored stretched fabric seats and backs, a round aluminum base and aluminum arm rests, and a rectangular table with a tabletop made from porcelain tile with a natural stone look. The chairs are about 44 inches H x 26 inches L x 30 inches W. The table is about 29 inches H x 30 inches L x 26 inches W. Costco Item #966710 is printed on the hangtag, label and on the packaging.

The recalled chairs can break due to a missing metal washer plate, posing a fall hazard to consumers. Consumers should immediately stop using the chairs and contact Dimension to receive a free repair kit or a full refund. Consumers can contact Dimension at Dimension at (800) 598-6532 from 9 a.m. to 5 p.m. ET.

DimensionWasherPlate640

Number-966630-fairview-7Costco is also recalling the Agio Fairview 7 Piece Woven Dining Set, Costco Item Number 966630.

There have been reports that the legs of the chairs can fracture, causing the chair to bend or fall backward, and presenting a possible risk of injury from a fall.

The units were sold from between January 2014 and March 2014 and also distributed by Dimension Industries of Taiwan. Consumers should return the product to Costco or contact Agio at 1-800-598-6532 to arrange a pickup.

Invasion of the Saucer Men.

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This Halloween season we offer another “scary” movie for you. We present Invasion of the Saucer Men.

This one is actually not scary, nor was it intended to be. There are a few scary scenes to be sure. Such as the crawling hand. The overall attempt of this gem, however, was to counter other juvenile delinquent movies of the time.

Like many other movies, an attempt at a remake was filmed, albeit poorly. There is nothing like the original on this one. The best comical saucer movie since this 1957 classic was the 1986 Tim Burton movie Invaders from Mars.

Real Foods Of Seattle, LLC Issues Allergy Alert On Undeclared Egg In Mexican Cheddar Dip

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ucm418650October 12, 2014 – Real Foods of Seattle, LLC, (WA) is initiating a voluntary recall of 96 units of “Mexican Cheddar Dip” product due to an undeclared allergen. This product contains egg, an allergen, which is not declared on the bottom label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

The product subject to the recall:

STORE ITEM DESCRIPTION UPC NUMBER SELL BY DATE
QUALITY FOOD CENTERS 10-oz package of Mexican Cheddar Dip 0 30223 00952 8; or
0 30223 00968 9 10/09/14;		 10/10/14;
10/11/14.

The above product was manufactured between 10/04/14 and 10/06/14 and shipped between 10/05/14 and 10/07/14 to a limited number of QUALITY FOOD CENTER stores in Washington State only. The newly launched product may bear one of the two UPC numbers listed in the table.

This product was distributed and sold in a limited number of Quality Food Center stores in the following cities: Everett, (WA); Mill Creek, (WA); Sequim, (WA); Bothell, (WA); Port Townsend, (WA); Belfair, (WA); Lacy, (WA); Kirkland, (WA); Bellevue, (WA); Redmond, (WA); Stanwood, (WA) and Port Hadlock, (WA).

No other products or code dates are affected by this recall.

There have been no adverse reactions or illnesses attributed to the recalled item.

Customers who have purchased this product and are sensitive to egg products or have egg allergies should not consume the above-mentioned product. This product may be returned to the store where purchased for a full refund.

Consumers may call Patrick Quatsoe at 206-354-1921 for any further information Monday to Friday, between the hours of 8am-5pm (PST).

ucm418652

California Olive And Vine Announces The Voluntary Recall Of Pumpkin Seed Pesto

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California Olive and Vine, LLC of Sutter, CA is taking precautionary measures and voluntarily recalling Pumpkin Seed Pesto because of irregular lab results. The company found that the jarred pesto may have been improperly processed, making it susceptible to contamination with Clostridium botulinum.

This food product was distributed under the Williams-Sonoma label, nationwide, since September 2014. The product labels have the following SKU numbers 6404305, 6389043 and is sold in an 8 ounce glass jar, as pictured below. The company has made the deliberate decision to recall this product to ensure the safety of their customers. The company has not been notified of any illness associated with this product.

No other products from this company are affected.

Ingestion of botulism toxin may lead to serious illness and death. To date, there have been no reports of any illnesses or contamination of the product.

Symptoms from Botulism are as follows: general weakness, dizziness, double vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distention and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Consumers are warned not to use the product even if it does not look or smell spoiled.

California Olive and Vine immediately segregated its entire inventory of this product and has notified Williams-Sonoma and CDPH directly. Consumers who have purchased the recalled Pumpkin Seed Pesto are urged to dispose of the product or return it to the place of purchase for a refund. Consumers with questions may contact the company Monday through Friday between 10am and 4pm.pesto

Candidate for AZSOS misrepresents facts

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Arizona-electsPHOENIX – Candidates often make inflammatory statements as a tactic to provoke a sense of mistreatment to curry favor with voters. However, blatant mischaracterizations about Arizona’s system of elections must be corrected. With less than three weeks before the General Election, current Secretary of State Ken Bennett believes it’s necessary to clear up inaccurate information being presented by Terry Goddard over the past few months.

The latest examples occurred during the Clean Elections Debate, hosted by Arizona PBS. During the broadcast, Mr. Goddard made two statements that were either terribly ignorant or deliberate misrepresentations of the truth for political gain.

“I’m confused where Mr. Goddard came up with amount of $2 million to implement the so-called Dual Track, or bifurcated system of voting in the primary,” said Secretary Bennett. Truth is, our counties will spend about $500,000 for both the primary and general elections. This system—one that I’ve repeatedly said is not ideal for election officials—was developed in response to two conflicting directives. One from Arizona’s voters, (Prop. 200) and the U.S. Supreme Court (Arizona v. Inter Tribal Council of Ariz., Inc.) As I’ve publically said before, and I’ll ask Mr. Goddard, which directive should we ignore; Arizona’s voters or the Supreme Court?

“In addition, I’m troubled by Mr. Goddard’s characterization that students, ‘who have to vote a federal ballot, are treated as second class citizens,’ which is patently false and simply absurd. College students do not have to vote a federal form. Those voting a federal ballot are simply doing so because they haven’t provided proof-of-citizenship to our County Recorders, a requirement approved by voters in 2004. Election officials around the state are committed to treating each voter equally and for Mr. Goddard to assume otherwise is offensive to elections officials statewide.

“Combined with his conspiratorial accusation of voter suppression when he declared ‘independent voters get only one chance to cast a ballot,’ I question Mr. Goddard’s fundamental understanding of how elections work in Arizona. While I certainly appreciate Mr. Goddard’s compliment about my singing voice during the debate, I would ask he either learn the songs or stop making up the lyrics.”

Coalition to Stop Gun Violence harasses American sheriff in Maryland

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According to delmarvanow, the Coalition to Stop Gun Violence is attempting to strip the teaching certificate of Wicomico County Sheriff Mike Lewis because of his comments on gun control efforts.

The harassment is generated because Sheriff Lewis stated that he would uphold his oath to the Constitution of the United States and not allow the federal government to strip gun owners in his county.

He is quoted:

As long as I’m the sheriff in this county, I will not allow the federal government to come in here and strip my citizens of their right to bear arms. I can tell you this, if they attempt to do that, it would be an all-out civil war, no question about it.

Sheriff Lewis stated that the Second Amendment does not come up in training and their concentration is on the Fourth Amendment.

The Sheriff goes into detail about hunting in his area including the hunting he has done. However hunting is not protected by the Second Amendment. Hunting is protected by the Ninth Amendment.

The Coalition has collected 1,400 signatures through an online petitions to present to the Maryland Police Training Commission. Like voter fraud prevalent in elections, online petitions are easy to fake and are generally used to collect emails for spam. They are largely ignored by Congress.

Ladd Everitt, director of communications for the Washington-based gun control group, was quoted as saying:

When you employ violence against your government essentially to effect policy decisions, you are damaging the principle of political equality.

Everitt did not comment on the recent comment by Joe Biden, Vice-President of the United States, that he is praying for another shooting of a high profile victim to further the gun control agenda.

The founders took a different view from Everitt. In Federalist Paper No. 29, Concerning the Militia, Alexander Hamilton wrote:

If a well-regulated militia be the most natural defense of a free country, it ought certainly to be under the regulation and at the disposal of that body which is constituted the guardian of the national security. If standing armies are dangerous to liberty, an efficacious power over the militia, in the body to whose care the protection of the State is committed, ought, as far as possible, to take away the inducement and the pretext to such unfriendly institutions.

The National Guard is not the militia, but a branch of the United States Army. The Constitution does not allow the militia to be used outside of the borders of the United States. Though some of the soldiers in the National Guard have shown in the past that they are not willing to disarm American citizens.

The founders believed that (From No. 29):

The attention of the government ought particularly to be directed to the formation of a select corps of moderate extent, upon such principles as will really fit them for service in case of need. By thus circumscribing the plan, it will be possible to have an excellent body of well-trained militia, ready to take the field whenever the defense of the State shall require it. This will not only lessen the call for military establishments, but if circumstances should at any time oblige the government to form an army of any magnitude that army can never be formidable to the liberties of the people while there is a large body of citizens, little, if at all, inferior to them in discipline and the use of arms, who stand ready to defend their own rights and those of their fellow-citizens.

It is quite clear that the founders believed that a milita armed equal to any standing army—which includes DHS, FBI, EPA and all of the other standing armies in the federal government—was necessary for liberty and freedom. According to the Constitution, the militia is also to be used to protect the borders against invasion.

It is also clear that the object of the militia was to protect the rights of their fellow legal Untied States citizens and not to suppress them.

California Firm Expands Recall of Beef Products Due To Possible Processing Flaw

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640-galinasWASHINGTON – Galant Food Company, a San Leandro, Calif. establishment, is recalling an additional 130 pounds of beef products because the meat filling used in the products did not meet its cooking critical limit, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The additional products subject to the recall include: [Labels (PDF Only)]

  • 6.5-oz. Paramount Beef and Cheese Piroshki, 12 per case, with case codes 092214
  • 7-oz. Galinas Original Beef and Cheese Piroshki, 12 per case, with case codes 092314

The products, which bear the establishment number “EST. 9014,” were produced Sept. 22 through 23, 2014 and then shipped to a distributor in the San Francisco Bay area.

The problem was discovered by the company when visiting its distributor and identifying that the products, as those in the initial recall, contained the same filling that did not reach lethality.

FSIS and the company have received no reports of adverse illnesses due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

This is a Class I recall which means a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

Germ-Killing Robots Deployed to the Republic of Liberia To Aid in Battle Against Ebola Virus

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IMG_8856-thumb7MEMPHIS Aug. 15, 2014 /PRNewswire/ – Two 5-foot-5 superbug-slaying machines were deployed from the United States yesterday en route to JFK Hospital and ELWA Hospital in Monrovia, Republic of Liberia, where they will aid in the fight against the deadly Ebola virus outbreak.

The devices, known as TRU-D SmartUVC(TM), will help disinfect health care environments where Ebola patients are being treated. TRU-D is the only portable UV disinfection device on the market with Sensor360™ technology, which calculates the time needed to react to room variables – such as size, geometry, surface reflectivity and the amount and location of equipment in the room – and effectively deliver a lethal dose of UV-C light during a single cycle from a single, central location in the room. It works by generating UV light energy that modifies the DNA structure of viral pathogens, like Ebola, so that they cannot reproduce. Viruses that cannot reproduce cannot colonize and harm patients. Additionally, TRU-D has been validated by more than 10 studies to be 99.99 percent effective in eliminating the most common pathogens that cause health care-associated infections.

The Ebola virus is the cause of a viral hemorrhagic fever disease that is highly contagious through bodily fluid transmission. Symptoms of the disease include fever, headache, weakness, aches, diarrhea, vomiting, stomach pain, lack of appetite and abdominal bleeding.

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