Category Archives: National Government

Exceptional Health Products Issues Allergy Alert On Undeclared Soy And Milk Allergens In Angel Wings™- Daily Multi 120 Capsules

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ucm497171Exceptional Health Products of Tulsa Oklahoma is recalling Angel Wings™ – Daily Multi 120 Capsules because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

The following product was distributed nationwide to consumers through mailorder.

Product Name: Angel Wings™ – Daily Multi 120 Capsules

Lot Numbers: 14656, 14657, 15109, 15489, 15488, 15616, and 16007

This voluntary recall has been initiated because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product.

No illnesses have been reported to date. This was brought to our attention by the Food and Drug Administration that found inconsistencies with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation.

The recalled lot numbers began shipping nationwide on December 23, 2014. If you find the recalled lot numbers on the bottom of any bottle you have inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall.

If you have any questions, call 888-548-0477 Monday thru Friday 8:00 AM to 5:00 PM CST. We are sorry for this inconvience and appreciate your assistance.

Kaibab National Forest temporarily suspends issuance of personal use cinder permits for Moonset Pit

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WILLIAMS — The Kaibab National Forest is temporarily suspending the issuance of personal use cinder permits for Moonset Pit on the Williams Ranger District due to operations underway to expand and improve the popular cinder collection area.

Moonset Pit is located just west of Parks, off a dirt road, east of Spitz Springs and to the north of old Route 66. The Kaibab National Forest, working in conjunction with Coconino County, is undertaking a pit expansion project over the next two years in order to make the area safer and also easier to access and use for cinder collection purposes.

Specifically, several acres of trees will be cut and then removed. It is expected this wood will be made available to the public as free firewood once that work has been completed. Then, the existing material in the pit will be moved and rearranged in order to create a more stable and durable structure.

“This pit expansion project is really about public safety,” said Deirdre McLaughlin, lands and minerals staff officer for the Williams and Tusayan districts of the Kaibab National Forest. “We had personal use cinder collectors in the pit who would dig into the material and then have issues with the top collapsing in. We have to restructure the pit so that we don’t have those potentially dangerous situations.”

While the expansion and improvement project is underway, the Kaibab National Forest will not issue personal use cinder permits for Moonset Pit. However, cinder collectors will still be able to obtain personal use permits for W Triangle Pit, also located on the Williams Ranger District. Individuals interested in obtaining a personal use cinder permit should contact the Williams Ranger District office at (928) 635-5600.

A portion of Moonset Pit is also made available by Kaibab National Forest to members of the public to dispose of natural forest debris on specific days in order to assist residents in creating a defensible space around their homes and property. This public service will continue to be offered and will not be impacted by the expansion project. To view open pit dates and additional information on the wildfire risk reduction service, visit http://go.usa.gov/cuYbP.

Consumer Labels for Broadband Services

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Comparing prices, performance and network practices of broadband service providers can be challenging, even for savvy consumers. With this in mind, the FCC created Open Internet transparency rules requiring providers to convey sufficient information for consumers to make informed choices about available broadband services. Based on recommendations from its Consumer Advisory Committee, the FCC provides templates for broadband labels – one for landline and one for mobile – that service providers may use to supply consumers with information about their services.

If a provider uses a broadband label template, here’s the type of information you can expect to see:

  • Pricing details, including all of the various charges that seem mysterious to consumers – overage fees, equipment fees, early termination fees, other monthly fees beyond service fees such as insurance, administrative fees, or regulatory recovery fees.
  • Monthly data allowance – namely, the carrier-defined plan limit after which consumers will incur additional charges.
  • Broadband speed and other performance metrics.
  • Network management practices – namely, precautions providers may take to manage heavy traffic on their networks.

Service providers who use the labels will satisfy the FCC’s requirement to make transparency disclosures in the proper format, or a format that meets the needs of consumers. However, providers may still be in violation of FCC rules if the content of their labels is misleading or inaccurate or if they make misleading or inaccurate statements to customers in ads or elsewhere. In such cases, consumers can file complaints with the FCC at https://consumercomplaints.fcc.gov.

The new rules will go into effect later this year, but service providers may begin using the broadband label templates anytime. The labels can serve as a helpful comparison shopping tool for consumers. Look for and consider them when you shop for service.

More information

Kaibab National Forest to offer firewood permits

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WILLIAMS — The Kaibab National Forest will offer firewood cutting permits for the 2016 fuelwood season beginning April 15 for the Williams and Tusayan districts and May 2 for the North Kaibab district.

The minimum cost for a personal use fuelwood permit is $20, which is good for four cords of wood. Firewood cutting permits can be purchased at the following locations and during the specified hours Monday through Friday, excluding federal holidays:

  • Williams Ranger District, 742 S. Clover Road, Williams; 8 a.m. to 4 p.m.; (928) 635-5600
  • Tusayan Ranger District, 176 Lincoln Log Loop, Grand Canyon; 8 a.m. to 4:30 p.m.; (928) 638-2443
  • North Kaibab Ranger District, 430 S. Main St., Fredonia; 8 a.m. to 4:30 p.m.; (928) 643-7395

The 2016 firewood cutting season runs from April 15 to Dec. 31 for the Williams and Tusayan districts and from May 2 to Nov. 30 for the North Kaibab district.

Free-use permits may also be available for specific areas on the forest. Individuals seeking such permits should check with the appropriate ranger district office for availability, locations and other information.

All permits issued will include a map and detailed cutting regulations as well as load tags, which must be physically attached to each ¼ cord of firewood and visible from the rear of the vehicle. The goal of this load tagging system is to ensure accountability for the amount of wood removed from the forest.

The removal of fuelwood is permitted only from National Forest lands on the district for which the permit is issued. Fuelwood cutters are reminded to take note of property boundaries and cut only on National Forest lands.

Fuelwood cutters should be aware that chainsaws can throw sparks and ignite grasses and brush. Always carry a shovel and a fire extinguisher or water in case of a fire start. Additionally, all chainsaws must be equipped with a stainless steel spark arrestor screen. Cutters should check with forest offices periodically for information about the implementation of fire restrictions.

Detailed firewood cutting information and maps for each ranger district are available on the Kaibab National Forest website at www.fs.usda.gov/goto/kaibab/fuelwood.

Voluntary Recall of Fetch™ 2 Aspiration Catheter

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MARLBOROUGH, Mass. – Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs
FETCH2 US
109400-001
FETCH2 OUS
109400-002
FETCH2 Canada
109400-003
FETCH2 Japan
109400-004
FETCH2 EU
109400-005

Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    or
  • Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211 and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves

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On March 3, 2016, Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. This recall only affects the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016.

The recalled products are specific lots of Model Numbers 8210 and 8211. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 26,550 devices have been manufactured, with 5,283 distributed in the United States. The condition that led to the recall may affect approximately 2.4% of recalled devices.

Vascular Solutions Inc. voluntarily initiated the recall on March 3, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific lots subject to the recall and included instructions on how to return the affected products.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:

For further information, connect to www.vasc.com.

Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon

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ucm495082Progressive Gourmet Inc. of Wilmington, MA, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The item is produced for Hannaford Supermarkets.

The product comes in a 9 ounce carton, marked with Best Before: 1 1117 on the back of the retail carton. Note, no other production runs of this product are impacted by this recall.

The potentially impacted Edamame Rangoon were possibly sold to consumers at select Hannaford stores located in Maine, Massachusetts, New Hampshire, Vermont and New York.

A consumer reported the mislabeling incident. The firm has initiated prompt corrective actions to prevent future mislabeling. No illnesses have been reported to date in connection with this product.

Consumers who have purchased 9 ounce packages of the edamame rangoon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-224-7630 (9:00 am – 5:00 pm Monday through Friday EST).

Pilgrim’s Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination

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Class I recall is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

WASHINGTON — Pilgrim’s Pride Corp., a Waco, Texas establishment, is recalling approximately 40,780 pounds of fully cooked chicken nugget products that may be contaminated with extraneous plastic materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The fully cooked chicken nugget products were produced on Oct. 5, 2015. The following products are subject to recall: [Label (PDF Only)]

20-lb. cardboard boxes containing two, 10-lb. clear plastic bags of fully cooked chicken nuggets labeled as “GOLD KIST FARMS Fully Cooked Whole Grain Popcorn Style Chicken Patty Fritters.”

The products subject to recall bear establishment number “EST. P-20728” inside the USDA mark of inspection and include package codes 5278105021, 5278105022, 5278105023, 5278105000, and 5278105001. These items were shipped for institutional use to Arizona, California, Colorado, Florida, Georgia, Kansas, Kentucky, North Carolina, Nebraska, Oklahoma, Tennessee, Texas, and Utah.

The problem was discovered after the firm received several consumer complaints regarding plastic contamination of the chicken nuggets. The firm notified FSIS personnel of the issue on April 6, 2016.

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.

Kaibab National Forest Supervisor’s Office front desk to be closed for much of the rest of April

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WILLIAMS — The front desk of the Kaibab National Forest Supervisor’s Office in Williams will be closed from April 11 through April 29 due to short staffing. Members of the public seeking passes or permits, information or other visitor services during that time are asked to go directly to the Williams Ranger District office, also located in Williams.

The Williams Ranger District office is located at 742 S. Clover Road in Williams and is open from 8 a.m. to 4:30 p.m. Monday through Friday. The Williams Ranger District office offers all the same resources as the Supervisor’s Office, so visitors shouldn’t experience any disruption of service.

The Kaibab National Forest Supervisor’s Office will reopen to the public with its full offering of resources and services on May 2.

The Williams Ranger District office can be reached by telephone at (928) 635-5600.

Prescribed burn planned to begin Sunday east of Tusayan

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image004TUSAYAN — Crews plan to begin ignitions on a 264-acre burn on the Tusayan East Prescribed Fire Project on Sunday and intend to continue burning for approximately two days in the area if conditions remain favorable. The burn area is located just south of Grand Canyon National Park and east of the Town of Tusayan.

Smoke may be visible from Highway 64 and in the communities of Valle and Tusayan. Light smoke may linger overnight and in the early morning hours. To minimize smoke impacts, fire managers will only conduct ignitions when conditions exist that will allow smoke to ventilate away from sensitive areas.

Smoke is expected to disperse to the east and northeast during the day. Residual smoke may settle into drainages and low lying areas overnight but will dissipate rapidly throughout the morning hours.

Prescribed fires are essential tools for restoring the forests in a fire-adapted ecosystem, and smoke is an unavoidable byproduct of these efforts. Fire managers strive to minimize smoke impacts to the community as much as possible. Burns occur when winds and other atmospheric conditions will push the majority of smoke away from homes and ultimately limit the number of days smoke is in the air. Fire managers work closely with the Arizona Department of Environmental Quality, partners in the Grand Canyon National Park, as well as surrounding Native American tribes to monitor air quality.

Notifications of upcoming prescribed burns are provided regularly throughout the season. The public can find this information online or through a recorded hotline. Contact your local Kaibab National Forest office for additional information.