Eclectic Institute Voluntarily Recalls Specific Dietary Supplements Containing Gotu Kola

Eclectic Institute, Sandy, Oregon is voluntarily recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) capsules because of potential Salmonella contamination.

Salmonella is 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, nausea, vomiting and abdominal pain. In rare circumstances, Salmonella infection 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.

Eclectic issued this voluntary recall because a routine audit of micro-testing records revealed that the micro-tests for one batch of Gotu Kola and one batch of Bladderwrack had conflicting lab results – one positive and one negative for Salmonella.

No adverse effects or illnesses have been reported to date in connection with either of these products.

The products that are subject of this voluntary recall were sold by several different methods. Eclectic Institute sold these products to retailers, individuals, and health practitioners throughout the United States. The affected lots of Gotu Kola (Centella asiatica) products were sold from September 14, 2011 to December 14, 2011. The affected lots of Bladderwrack (Fucus vesiculosus) products were sold from July 14, 2011 to December 14, 2011.

This recall affects only those products with the lot numbers listed in the table below. No other Eclectic Institute products are affected by this recall. All of the freeze-dried capsules were packaged in either glass or plastic bottles. Lot numbers can be found on the bottom of the label of the product.

The specific products affected by this recall are:

Product Name	UPC Code	Item Number	Lot Number
Centella asiatica	no UPC	1771945	15404
Gotu Kola	23363-30507	3050700G	15404
	23363-30907	3090700G	15404
	23363-30907	3090700	15404
Ginkgo/Gotu Kola combination	23363-31503	3150300	15368 & 15487
	23363-31503	3150300G	15368 & 15487
	23363-31903	3190300	15368
Fucus vesiculosus	no UPC	1773645	15391
	no UPC	1773690	15391
Bladderwrack	23363-30415	3041500	15186
	23363-30515	3051500G	15391 & 15306
	23363-30515	3051500	15391
	23363-30915	3091500	15391 & 15306
	23363-30915	3091500G	15187

Consumers in possession of any of these voluntarily recalled products are urged to return the product to Eclectic Institute’s headquarters in Sandy, Oregon, for a full refund. Customers can also contact Eclectic Institute via telephone at 800.332.4372, Monday through Friday from 7:30 a.m. to 4:30 p.m. Pacific Standard Time, or by mail to 36350 SE Industrial Way, Sandy, OR.

 

December 2011: FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY)

Here is an urgent advisory, which you don’t see very often:

December 14, 2011 – St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.

The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. As communicated in the Physician Advisory Letter, the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.

St. Jude Medical reiterates that all leads with an externalized conductor, with or without an associated electrical abnormality, be reported to the company’s Technical Services Department at 1-800-722-3774. The company strongly encourages that any experience with screening of Riata leads for externalized conductors be shared with the company, including information regarding a lead or leads in which externalized conductors are not present. If a lead has been removed from the patient, St. Jude Medical requests that it be returned to the company, at company expense, for failure analysis to further understand this particular failure mechanism. All reports and returns received by St. Jude Medical of Riata leads exhibiting externalized conductors, irrespective of whether there is an associated electrical abnormality, are reported to FDA as a Medical Device Report (MDR). Any adverse reactions experienced with the use of this product, and/or quality problems also should 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, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

St. Jude Medical acknowledges that the clinical implications of leads with electrically intact externalized conductors are not fully known at this time. Consequently, more data are required in order to assess if specific patient subgroups with electrically intact externalized conductors are at greater risk or should be managed differently. Patients who require frequent defibrillation or who are pacemaker dependent may be considered to be at greater risk. It is recognized that physicians may choose to individualize the approach to management of electrically intact externalized conductors based on individual patient characteristics. The potential risks associated with externalized conductors as well as the potential risks and benefits of management options should be considered and discussed with patients.

“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads,” said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society (HRS) president and a member of St. Jude Medical’s Medical Advisory Board (MAB). Also, over the next several weeks, there are two public meetings scheduled to discuss Riata and associated clinical recommendations: A Riata Leads Issue Webinar sponsored by the Heart Rhythm Society on Dec. 21, 2011 and a Riata ICD Lead Summit sponsored by the Minneapolis Heart Institute Foundation on Jan. 20, 2012. Any additional consensus opinion developed from these meetings, including any additional screening efforts, will be addressed by St. Jude Medical and, if appropriate, will be communicated to the physician community.

The company and its independent MAB have recommended the following related to patient monitoring:

• For leads that do not exhibit externalized conductors, continue to monitor the patient’s implanted system at regularly scheduled visit intervals every three to six months as per Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA) consensus with particular attention to diagnostic information related to defibrillation lead performance.
• For leads that exhibit externalized conductors with no electrical abnormality, continue to monitor lead and system performance as per HRS/EHRA guidelines. The value of screening x-ray or fluoroscopy for patients with leads that exhibit no electrical abnormalities is unknown at this time and therefore, the risk of increased radiation exposure for monitoring should be weighed against using remote monitoring and in-clinic follow-up for detection of electrical anomalies. Prophylactic explant or replacement of a lead without electrical dysfunction is not recommended.
• For leads that exhibit externalized conductors with an associated electrical abnormality, management of the patient may include x-ray, fluoroscopy (cine), or additional testing including provocative methods such as shoulder and arm movements and deep respiration while looking at the surface ECG and intracardiac electrograms⁽¹⁾. Consideration should be given to prophylactically replacing leads with observed electrical abnormalities. If the leads are replaced, the risks and benefits of removing the old leads, or leaving them in place, should be carefully considered.
• Currently there is no expert consensus regarding whether patients undergoing pulse generator replacement should undergo fluoroscopy or lead replacement if an externalized conductor without electrical anomalies is present. This is, in part, because the risk versus benefit of replacing a lead in such a patient may vary from patient to patient and center to center. Consideration of fluoroscopy and lead replacement at time of pulse generator replacement should be individualized based on specific patient conditions and circumstances.

St. Jude Medical strongly encourages that whenever possible, remote monitoring and patient alerts be used to detect as early as possible any electrical changes that may be associated with externalized conductors. Changes in impedance from three high voltage lead vectors (RVC to Can, SVC to Can, and RVC to SVC), as well as pacing and sensing electrodes, can be detected by St. Jude Medical ICDs and provided to the clinician during the in-clinic device evaluation and may also be provided by means of remote monitoring (Housecall+, Merlin@Home, and Merlin.net). Data are displayed graphically to enable physicians to trend changes in impedance over time. Customized DirectAlerts® notifications allow physicians to monitor patient status between follow-ups. The noise reversion feature is designed to protect against non-physiologic high-rate event detection to avoid inappropriate shocks. Standard reprogramming such as turning on the EGM for Noise Reversion or ensuring that the ventricular rate EGMs are set to detection should also be considered. A patient may also become aware of electrical abnormalities even earlier when their device has a patient vibratory alert. Patients who receive a patient vibratory alert should contact their clinician.

In order to improve the understanding of this particular failure mechanism, St. Jude Medical has initiated a prospective study to evaluate the incidence rate and the long term performance of leads found to exhibit externalized conductors without an associated electrical abnormality, including an evaluation of any potential long term degradation of the ETFE insulation that is exposed outside of the silicone insulation. Enrollment has begun and is expected to continue to follow patients for up to two years. As information is gathered during this study, St. Jude Medical will update the physician community and, as appropriate, provide any specific updated recommendations for physicians to manage their patients.

St. Jude Medical is committed to keeping customers informed about product performance. If you have any questions or concerns, please do not hesitate to contact your local St. Jude Medical representative or the St. Jude Medical Technical Services Department at 800-722-3774.

1. Epstein, A.E. “Troubleshooting of Implantable Cardioverter-Defibrillators.”  Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy, 3rd ed., Eds. Ellenbogen, K.A., Kay G.N., Lau, C-P., Wilkoff, B.L., Philadelphia: Elsevier, 2007, pp. 1063-1086.
   

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4100 Pounds of Chicken Recalled in December

House of Raeford Farms, Inc., headquartered in Rose Hill, NC, today announced it is voluntarily
recalling a ready-to-eat chicken product due to potential presence of Listeria monocytogenes.

The Company is initiating this recall as a result of a sample submitted by an end user to an
accredited outside laboratory. The laboratory analysis indicated the presence of Listeria
monocytogenes.

The product being recalled is 4,141 pounds of House of Raeford – Royal Oven Roasted Skinless
Chicken Breast packed in 18.0-22.0 lb. cases containing two 9-11 lb. packages and shipped to
foodservice distribution centers in South Carolina, Georgia, and Florida. It carries the item code
94268 and a code date of 1270 (27 Sep 11). The recalled item was produced at House of
Raeford’s Further Processing plant in Raeford, NC bearing USDA Inspection number P-239A.

The recall is not connected with any reported illnesses or adverse reactions due to consumption
of this product. Consumers and media with questions regarding the recall should contact the
company’s Manager of Corporate Communications, Dave Witter, at 910-289-6895.

 

Source: http://www.houseofraeford.com/cms/upload/News%20Release%20-%20Voluntary%20Product%20Recall%281%29.pdf

Class I Recall for Draeger’s Infinity patient monitoring system

Draeger Medical’s Infinity Acute Care system, used to monitor patient vital signs and therapy, got a Class I recall from the FDA over concerns that its weight-based drug dosage calculator may make dangerously high recommendations.

The system may even recommend a dose as much as 10 times higher than that the safe amount, and “may cause serious adverse health consequences, including death,” according to the FDA.

In addition, the Infinity system’s electrocardiogram and blood pressure monitors may displaying DATA with a 5 or 10 second delay.

http://www.massdevice.com/news/fda-recalls-draegers-infinity-patient-monitoring-system-miscalculating-doses

 

Brain Imaging Modalites (List)

BRAIN IMAGING MODALITIES

• Autopsies
• X-ray and CT – Lesion data
• MR Angiography
• PET and SPECT
• MRI and fMRI
• DWI, DTI, Tractography
• Ultrasound
• Optical Coherence Tomography
• MEG and EEG

Voluntarily Recall of Limited Quantity of 12 oz Tejava® Premium Iced Tea

As a precautionary measure, certain production lots of Tejava® Premium Iced Tea in 12 oz glass bottles are being recalled nationwide due to the possible presence of glass fragments which could be harmful if swallowed. To date, there have been no reports of any illness or injury.

The 12 oz Tejava® production lot code dates being recalled are:

 

1BT220                     1BT221                   1BT222                  1BT223
1BT252                     1BT253                   1BT254                  1BT255
1BT277                     1BT278                   1BT279                  1BT280  
1BT313

 

These production codes can be found on the back of the bottle label and on the long panel of the case tray. They are for case UPC 6-54871-24901-2, four pack UPC 6-54871-04901-1, and single bottle UPC 6-54871-00901-5.

Consumers who have purchased the recalled products are asked to return the product to the store where it was purchased and coupons, product replacement, or credit will be issued.

Note: The 1 liter size of Tejava® Premium Iced Tea is NOT affected and is NOT part of this recall.

For further information, consumers should contact the Tejava® Consumer Hotline at 1-888-847-8742 or www.Tejava.com 24 hours per day, 7 days per week.

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HCG Weight Loss Products Removed from the Market

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.

The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.

The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.  Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm¹.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Mophie Recalls iPod Touch Rechargeable External Battery Case Due to Burn Hazard

he U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Rechargeable External Battery Case

Units: About 6,118

Importer: Mophie LLC, of Paw Paw, Mich.

Hazard: The battery case’s integrated circuit switch can overheat, posing a burn hazard to consumers.

Incidents/Injuries: Mophie has received 110 reports of the product becoming warm to the touch, 44 reports of the product deforming and nine reports of minor burns.

Description: The recalled product is a Mophie Juice Pack Air rechargeable external battery which consists of a lithium polymer battery built into a plastic case designed to snap onto the back of an iPod Touch 4G music player. The battery cases come in black, blue or red. Only battery cases with serial numbers that have the first five alphanumeric characters of TR113 through TR120 are subject to this recall. The serial number can be found inside the housing of the product.

Sold at: B& H Photo, Barnes & Noble, InMotion Entertainment, J&R Music World, Marine Corps Exchange stores, Amazon.com and mophie.com since April 2011 for about $50.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled product and contact Mophie for instructions on receiving a replacement product

Whirlpool & Sears Kenmore & KitchenAid Dishwasher Class Action Lawsuit Complaint Filed Over Alleged Overheating Of Electronic Control Board

A class action lawsuit has been filed against Whirlpool Corporation (“Whirlpool”), Sears Holdings Corp, and Sears Roebuck & Co, Inc. (“”Sears”) (collectively “Defendants”) in the United States District Court for the Central District of California (styled Steve Chambers, Lynn Van Der Veer, David Brown, Bach-Tuyet Brown, Kevin O’Donnell, Joseph Cicchelli, Kurt Himler, Susan Milicia, Gary LeBlanc and James Cashman v. Whirlpool Corporation, Sears Holdings Corp, and Sears Roebuck & Co, Inc. et al Class Action Case No. CV11-1733), alleging, among other things, that Whirlpool & Sears designed, manufactured, advertised, marketed, and sold KitchenAid and Kennmore brand dishwashers that contained defective electronic control boards that can overheat causing the control board and Dishwasher components to melt, smoke and burst into flames, according to the Whirlpool & Sears Kenmore & KitchenAid Dishwasher electronic control board overheating class action lawsuit.

 

The Whirlpool & Sears Kenmore & KitchenAid Dishwasher electronic control board overheating class action lawsuit complaint reportedly asserts claims for alleged violations of the California Consumer Legal Remedies Act, violations of unfair business practices act, fraudulent concealment, breach of implied warranty, breach of express warranty, strict products liability and failure to warn, unjust enrichment and negligence.

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CPSC November Recall List

Here is last month’s list of CPSC recalls

-Serious Head Injuries to Infants Continue Due to Falls from Bumbo Baby Seats Used on Elevated Surfaces;

Injuries occurring despite previous recall warning; parents urged to use caution

Due to the serious risk of injury to babies, CPSC and Bumbo International Trust of South Africa (“Bumbo International”) are urging parents and caregivers to never place Bumbo Baby Seats on tables, countertops, chairs or other raised surfaces. Infants aged 3-10 months old have fallen out of the Bumbo seat and suffered skull fractures and other injuries.

-Motion Sensing Wall Switches Recalled by HeathCo due to Electrical Shock Hazard

In cooperation with the U.S. Consumer Product Safety Commission, HeathCo, LLC of Bowling Green, Ky., is voluntarily recalling about 75,000 Heath®/Zenith and WirelessCommand® motion sensing wall switches. When the switches are in the auto mode and the light is off, a small amount of leakage current passes through the electric circuit, including the socket. If consumers fail to disconnect the power at the circuit breaker and make contact with both terminals inside the socket while replacing the bulbs, there is a risk of an electric shock.

-Columbia Sportswear Recalls Batteries Sold With Jackets Due To Fire Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Columbia Sportswear Company, of Portland, Ore., is voluntarily recalling about 220 pairs of Omni-Heat™ Lithium-Polymer rechargeable battery packs (two battery packs sold with each of 220 jackets). The batteries have a cell defect which can cause overheating, posing a fire hazard.

-Collective Brands Recalls KEDS Girls’ Shoes Due to Laceration Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Collective Brands, Inc., of Topeka, Kan., is voluntarily recalling about 45,000 KEDS® “Know It All” girls’ shoes. Ornamental stars on the heel of the shoe may loosen, posing a laceration hazard.

-Children’s Animal Slippers Recalled Due to Choking Hazard; Sold Exclusively at Family Dollar Stores

In cooperation with the U.S. Consumer Product Safety Commission, Family Dollar Services Inc., of Matthews, N.C., is voluntarily recalling about 160,000 Kidgets® Animal Sock Top slippers. The animal’s eyes can detach from the slippers, posing a choking hazard to young children.

-Liebherr Expands Recall of Refrigerators Due to Injury Hazard; Door Can Detach

In cooperation with the U.S. Consumer Product Safety Commission, Liebherr-Canada Ltd of Ontario, of Canada, is voluntarily recalling about 8,000 Liebherr Freestanding 30-Inch Wide, Bottom Freezer Refrigerators (About 5,700 built-in 30-inch wide, bottom freezer refrigerators were recalled in March 2011). The refrigerator’s door can detach, posing an injury hazard to consumers.

-Toys Safer This Holiday Season Due to Stronger Safety Rules; Recalls and lead violations are down; 180,000 child injuries per year is too high

It’s that time of year again, when parents, grandparents, and friends begin to prepare holiday toy shopping lists. The U.S. Consumer Product Safety Commission (CPSC) wants consumers to know that while safety should be at the top of everyone’s toy list, stronger federal rules are making a positive impact and restoring confidence in the safety of toys.

-Build-A-Bear Recalls Teddy Bear Swimwear Set Due to Strangulation Hazard

In cooperation with the U.S. Consumer Product Safety Commission and Health Canada, Build-A-Bear Workshop®, of St. Louis, is voluntarily recalling about 19,720 (in the United States) and 1,100 (in Canada) sets of swimwear with inflatable inner tube. The inner tube accessory can be pulled over a small child’s head, posing a strangulation hazard.

-Michaels Stores Recalls Ashland Brand Glass Vase Due to Laceration Hazard

In cooperation with the U.S. Consumer Product Safety Commission and Health Canada, Michaels Stores Inc. of Irving, Tex., is voluntarily recalling about 28,000 (in the United States) and 1,800 (in Canada) Ashland™ glass vases. The glass vases can break or fracture when a consumer picks them up, posing a laceration hazard.

-Arctic Cat Recalls ATVs due to Crash Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Arctic Cat Inc., of Thief River Falls, Minn., is voluntarily recalling about 1,384 Arctic Cat All-Terrain Vehicles. The ATV’s steering tie-rod can bend, causing loss of control which poses a crash hazard.

-W.P. Appliances Recalls Combination Grills/Griddles Due to Overheating and Electrical Shock Hazards; Sold Exclusively at HSN

In cooperation with the U.S. Consumer Product Safety Commission, W.P. Appliances Inc., of Hollywood, Fla., is voluntarily recalling about 27,000 Wolfgang Puck Electric Reversible Tri-Grill/Griddles. A defect in the electrical wiring of the electric grills/griddles can pose a risk of overheating, melting and an electrical shock hazard to consumers.

-Federal Judge Grants Permanent Injunction Against Brooklyn Sleep Products and Francisco Chavez

A federal judge granted a default judgment and a permanent injunction ordering Brooklyn Sleep Products Inc., of Brooklyn, N.Y., and its president Francisco Chavez, to stop manufacturing, importing, renovating and selling mattresses until they provide evidence that their mattresses comply with federal flammability laws.

-Joss Rock Climbing Cam Units Recalled by Sierra Trading Post Due to a Fall Hazard; Sold Exclusively by Sierra Trading Post

In cooperation with the U.S. Consumer Product Safety Commission, Sierra Trading Post, of Cheyenne, Wy., is voluntarily recalling about 1,280 Joss rock climbing cams. The recalled cams can fail unexpectedly after being set, posing a fall hazard.