Tag Archives: News

Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts

Posted on by

DUBLIN – Medtronic plc today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.

Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy.

  • If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
  • Patients and their caregivers should monitor the patient’s condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express

Posted on by

Orlando, Fla. – Fresh Express is announcing a precautionary recall of a limited number of cases of Organic Marketside Spring Mix.

The item subject to the recall is 5 oz. Organic Marketside Spring Mix marketed in a clear container with production code G089B19 and best-if-used-by date of APR 14, 2017 located on the front label, and UPC code 6 8113132897 5 located on the bottom of the container. The recalled salads were distributed only to Walmart stores located in the Southeastern region of the United States.

The recall was necessitated when Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad. Out of an abundance of caution, all salads manufactured in the same production run are being recalled.

No other Marketside salads are included in the recall. Fresh Express salads are not subject to a recall.

Walmart acted quickly to remove the product from store shelves.

Consumers who may have already purchased the recalled product should discard and not consume it. A full refund is available where purchased or by calling the Fresh Express Consumer Response Center toll-free at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Time.

Upon receiving notification, both Walmart and Fresh Express food safety and rapid response teams, in close coordination with regulatory authorities, acted immediately to review all relevant records, launch an intensive investigation and initiate product removal and recall procedures.

Fresh Express takes matters of food safety very seriously and rigorously complies with all food safety regulations including the proscribed Good Agricultural Practices. In addition, a range of stringent controls are in place during growing and harvesting to mitigate against field material from entering the raw product system. In manufacturing, additional controls including thorough washing and filtration systems as well as visual inspections that are designed to eliminate unwanted debris.

Recalled Product Details

  • Organic Marketside Spring Mix – 5 oz. clear container
  • Production Code of G089B19 and best-if-used-by date of APR 14 2017, located on the top label
  • UPC Code of 6 8113132897 5 located on the bottom of the container next to the bar code

Recalled Product Distribution

Fresh Express Precautionary Recall, 5 oz. Organic Marketside Spring Mix
(No other Marketside Salads and No Fresh Express Salads are included in this recall)

Brand PRODUCT NAME SIZE UPC PRODUCTION CODE BEST IF USED BY DATE POSSIBLE DISTRIBUTION STATES
Marketside Organic Spring Mix 5 oz. 6 8113132897 5 G089B19 APR 14 2017 AL, FL, GA, LA, MS, NC, SC, VA,

 

AZGFD applauds federal decision to withdraw proposed listing of two fish species under Endangered Species Act

Posted on by

PHOENIX – The Arizona Game and Fish Department applauds today’s decision by the U.S. Fish and Wildlife Service to withdraw its proposal to list two minnows, the headwater chub and a distinct population segment (DPS) of the roundtail chub in the Lower Colorado River Basin (Arizona and New Mexico), as threatened species under the Endangered Species Act (ESA).

The Service’s decision came as a result of new scientific classification information that in 2016 led the American Fisheries Society and the American Society of Ichthyologists and Herpetologists Joint Committee on the Names of Fishes – the recognized authority on fish taxonomy – to consider the headwater chub and roundtail chub (and the Gila chub, which is currently listed as endangered), to be a single species: the roundtail chub.

Arizona Game and Fish Department biologists in 2015 conducted a complete review of all data and scientific literature available to determine if the available science supported the recognized taxonomic designations of the three species of chub. The department’s review found no justification to support the separation of chub into three separate species, and concluded they should be classified as a single species.

Subsequently, Game and Fish formally requested that the American Fisheries Society re-evaluate the recognized taxonomic designation of the three species.

The analysis was assigned to the Joint Committee, which conducted months of review and listened to presentations by fisheries scientists on the morphology and genetic status of chub. In September 2016, the Joint Committee concluded there is no morphological or genetic data that define populations of roundtail chub in the lower Colorado River basin as members of more than one species.

“The Joint Committee’s determination last year, along with today’s U.S. Fish and Wildlife Service decision, is a huge win for chub and for those who manage and conserve chub in the lower Colorado River basin,” said Chris Cantrell, aquatic wildlife chief for Arizona Game and Fish. “The taxonomic history of this species has been debated for decades, which has influenced our management strategies and our ability to implement conservation on a range-wide basis. The decision will open doors to more opportunities to protect and conserve chub in Arizona.”

Arizona Sen. Jeff Flake said: “I am pleased to see the USFWS is paying attention to Arizonans and deciding against adding to an already lengthy list of threatened and endangered species in Arizona.”

Added Steve Spangle, the U.S. Fish and Wildlife Service’s Arizona Field Supervisor, in a news release: “Endangered Species Act determinations are founded on the best available science. When new science becomes available, especially midstream in a listing processes, we evaluate it and respond accordingly. Our withdrawal of the listing proposal for the former headwater chub and roundtail chub DPS reflects this new science indicating that these are no longer valid species.”

The Service, together with conservation partners, intends to conduct a species status assessment of the now-larger roundtail chub taxon. This includes the Gila chub, which has been protected under the ESA since 2005. The taxonomic revision of the chubs resulted in Gila chub being recognized as a part of the larger roundtail chub species, necessitating a re-evaluation of its ESA status. Pending this evaluation, the Gila chub will remain protected under the ESA. The Department encourages the Service to make swift resolution to remove the ESA status of Gila chub based on the findings of the Joint Committee and the best available science.

The Arizona Game and Fish Department looks forward to working with the U.S. Fish and Wildlife Service and all of its partners to ensure conservation of the roundtail chub throughout its expanded range.

Board of Supervisors adopt National Park Improvement Resolution

Posted on by

FLAGSTAFF – The Coconino County Board of Supervisors approved a resolution this week supporting the use of county resources for infrastructure improvements in the United States’ National Parks.

In 2016, the National Park Service estimated a deferred maintenance backlog of nearly $460 million in Coconino County, including necessary repairs to the visitor centers, aging historical structures, trails, sewers, drainage, roads, bridges, tunnels and other vital infrastructure of the county’s six National Parks, Monuments and Recreation Areas.

“The Board of Supervisors recognizes the importance and value of National Parks to both the county and our many visitors,” said Chairwoman of the Board of Supervisors Liz Archuleta. “Our goal with approving this resolution is that we can help support the necessary maintenance and improvements of these areas.”

Coconino County hosted more than seven million visitors to its National Parks in 2015. These visits brought an estimated $932 million in revenue to local communities adjacent to national parks in the State of Arizona.

“Coconino County’s economic foundation is built on visitation to National Parks, National Monuments, National Recreation Areas and public lands,” said Supervisor Art Babbott. “By adequately funding critical infrastructure- water lines, roads wastewater- we can strengthen our economies, improve visitor experience to these wondrous places and protect these landscapes for future generations.”

The County will forward on the resolution to Congressional representatives and the National Association of Counties to do further advocacy during federal budget negotiations.

ADOT kicks off Work Zone Awareness Week

Posted on by

PHOENIX – Give’em a brake, Arizona.

That’s the message the Arizona Department of Transportation is sending to drivers during National Work Zone Awareness Week. Through April 7, ADOT will join federal, state and local transportation organizations across the country to bring attention to the importance of being alert when driving in work zones.

Throughout this week on social media, ADOT will share personal stories about work zone safety from ADOT employees who work alongside speeding vehicles while building and maintaining Arizona’s highways. Motorists will see work zone awareness safety messages on overhead signs, too.

“Safety is the No. 1 priority at ADOT,” ADOT Director John Halikowski said. “When it comes to work zones, where vehicles can speed by just inches away, there are very few more dangerous places to spend a workday. We rely on motorists to pay attention when entering work zones, not only for the safety of our crews, but for drivers and passengers, too.”

According to the Federal Highway Administration, drivers and passengers accounted for 82 percent of work zone fatalities nationally in 2014, the most recent year with complete data. According to preliminary data for 2016, Arizona had seven fatal crashes in work zones, resulting in seven deaths, and 27 serious-injury crashes.

To protect motorists and those who build and maintain Arizona’s highways, follow these tips when traveling through work zones:

  • Pay attention: Observe and obey posted warning signs, as well as flaggers. You can be cited for disobeying a flagger’s directions.
  • Expect the unexpected: Speed limits might be lowered, travel lanes could be narrowed or eliminated and people may be working near your travel lane.
  • Slow down: Speeding is one of the leading causes of work zone crashes.
  • Merge safely: Do it early and carefully or as directed by signage instead of barging into a line of vehicles at the last moment.
  • Don’t tailgate: The most common crash in a work zone is the rear-end collision. Don’t follow too closely and, again, slow your speed.

For more information about work zone safety, visit azdot.gov/workzone.

Shoulder widening project on State Route 89A in Prescott Valley starts this week

Posted on by

PRESCOTT – The Arizona Department of Transportation will begin work on a nine-mile shoulder widening project this week on State Route 89A between Coyote Springs Road and Legend Hills Drive (mileposts 324 to 332) in Prescott Valley.

Drivers are encouraged to be alert for increased construction activity throughout the work zone and adhere to reduced speeds as work begins.

Work hours initially for this project are Monday through Thursday between 6 a.m. to 6 p.m. through the end of the month and then construction will be a 24-hour operation towards the beginning of May.

This $2.4 million project consists of widened shoulders, resurfacing, installing new signage, drainage improvements, new pavement markings and other miscellaneous work.

Drivers should proceed through the work zone with caution, slow down and watch for construction personnel and equipment.

2017 elk, pronghorn hunt draw results available

Posted on by
PHOENIX – The Arizona Game and Fish Department has completed its 2017 hunt draw for elk and pronghorn. 

The results are available by visiting https://draw.azgfd.gov/ and scrolling down to “View results and bonus points,” or by calling the department at (602) 942-3000 and pressing “2.” 

By the numbers:
  • 25,613: The total number of permit-tags issued.
  • 172,736: The total number of those who applied for hunts or bonus points.
  • 129,743: The total number of applications submitted (paper application and online).
Permit-tags for successful applicants, along with refunds for those who were unsuccessful in the hunt draw, are expected to be mailed by Friday, April 21.
In the meantime, there are 791 leftover elk permit-tags – 731 for the minimal occurrence zone/low density (general) hunts in game management units 12A, 12B, 13A and 13B. All remaining permit-tags will be available for purchase on a first-come, first-served basis as follows: 

  • By mail: Applications will be accepted by mail beginning at 8 a.m. April 24 and must be addressed to: Arizona Game and Fish Department, Attn: Draw/First Come, 5000 W. Carefree Highway, Phoenix, AZ  85086. Do not mail applications to a Post Office (P.O.) box.
  • In person: If any leftover permit-tags remain, they also will be available for purchase beginning at 8 a.m. May 1 at any of the seven department offices statewide. 
Some of the leftover elk tags are for Hopi hunt open areas and are available to everyone, both tribal members and non-tribal members, through the first-come, first-served process.

A number of leftover elk tags remain for military hunts at Camp Navajo, for those who qualify. For more information, visit https://dema.az.gov/army-national-guard/camp-navajo/garrison-operations/camp-navajo-hunting-information, e-mail sarah.b.golabiewski.mil@mail.mil, or call 928-773-3225. 

Now that the draw is over, it’s time to start planning that hunt. The first step is to open an AZGFD customer portal account. It’s quick, easy and – best of all – it’s free. Just visit www.azgfd.gov, click on the “Sign in to Account” button in the upper right-hand corner of the home page, then select the “Create an Account” option, filling in the requested information.

As a reminder, all fields requesting information must be completed. For example, both Social Security and Department ID fields must be completed. If your Social Security number is also your Department ID number, your Social Security number must appear in both fields.

The portal allows customers to create a secure account where they can manage and view their contact information, as well as their license and draw results history and bonus points, in their personal “My AZ Outdoors” section. A portal account is a mobile-friendly, convenient way to access the online license purchase and hunt draw application systems.

Another benefit of having a portal account is the opportunity to sign up for the “I Support Wildlife” program, which helps fund wildlife conservation in Arizona. An annual membership for $25 includes access to the new “premium” version of the Recreational Access Arizona (RAA) online mapping application, the latest fish stocking reports, an “I Support Wildlife” window decal and a one-year subscription to the award-winning Arizona Wildlife Views magazine.

The premium RAA mapping application is a significant upgrade over the free version and is a tremendous tool when planning your hunt. It is designed to work on all mobile devices (with active cell service) and lets you see your current location in reference to different data layers, including Game Management Units, wildlife waters, Arizona land ownership, an ESRI USA Topographic (USGS 24k Topo) basemap and more. Even better, the premium mapping application allows you to create your own point locations and automatically save and sync that data to all of your devices.

“I Support Wildlife” bridges the widening gap between wildlife facing new threats and a sharp increase in the cost of conservation. The department receives no Arizona tax dollars to support its mission to conserve and protect more than 800 wildlife species, the most of any non-coastal state in the U.S.   

For questions about opening a customer portal account, call the department at (602) 942-3000 and press “7.”

ADEQ holding a meeting to discuss changes to swimming pool rules

Posted on by

PHOENIX – The Arizona Department of Environmental Quality (ADEQ) invites stakeholders to attend a stakeholder meeting to discuss proposed changes to swimming pool rules, promulgated in 1998, which are woefully out of date.

ADEQ is required by A.R.S. § 49-104(B)(12) to have rules that prescribe minimum design standards and sanitary conditions at any public or semi-public swimming pool or bathing place. ADEQ proposes to update these standards by referencing a national standard or model code for all public and semi-public swimming pools.

Attend the meeting in person or via conference call.

View meeting details and agenda >

In person:

When:  Mon., April 17, 2017, 10:00 a.m. to 12:00 p.m.
Where: ADEQ, 1110 W. Washington St., First Floor, Room 145, Phoenix, AZ, 85007
Directions to ADEQ >
Parking at ADEQ >

Omnibus Bill SB 1183 Passes, Eliminating and Reducing Unnecessary Regulatory Burden

Posted on by

PHOENIX – Arizona Department of Environmental Quality officials today thank Governor Doug Ducey for signing SB 1183 into law. Sponsored by Senator Griffin, the legislation will reduce unnecessary regulatory burdens, while continuing to promote environmentally responsible economic growth.

In response to Governor Ducey’s Executive Order 2015-01, SB 1183 is the next step of ADEQ’s comprehensive evaluation of existing statute and rule to identify and remove, simplify or correct duplicative, contradictory and ambiguous regulatory hurdles. SB 1183 successfully streamlines five statutes, and will also result in the amendment or termination of eight sections of rule from the Arizona Administrative Code, offering tangible benefits to Arizona taxpayers and industry.

Senator Gail Griffin, R-14 Senate Majority Whip, said today, “I am glad to stand with Governor Ducey and sponsor legislation to update and repeal unnecessary and outdated regulations that burden our economy.”

“As we continue to eliminate waste in our processes through our ongoing LEAN transformation, we increase our capacity to do more mission-critical work,” said Arizona Department of Environmental Quality Director Misael Cabrera. “Cutting this waste from our regulations is another step toward more effective government that operates at the speed of business.”

SB 1183 highlights:

  • Septage Hauler – Removes redundant regulatory and fiscal burdens from regulated septage haulers by providing ADEQ the authority to eliminate, in rule, duplicative state and county licensing and inspection fees. (ARS §49-104)
  • Dry Well Driller Licensing – Eliminates redundant regulatory oversite from ADEQ for licensure already administered by the Arizona Registrar of Contractors. (ARS §49-333)
  • ADEQ Recycling Emblem – Eliminates statutory requirements for rules regarding establishment and use of a state recycling emblem. (ARS §49-833, R18-13-2501)
  • State-owned Hazardous Waste Facilities – Eliminates a duplicative hazardous waste transportation requirement that is already administered under the jurisdiction of the Arizona Department of Transportation. (ARS §49-905)
  • Toxic Substances List – Removes an outdated and contradictory provision related to the federal Toxic Substances List. (ARS §49-968)

Flagstaff Unified School District seeking Governing Board applicants

Posted on by

FLAGSTAFF – Coconino County Superintendent of Schools Risha VanderWey is seeking applicants for appointment to the Flagstaff Unified School District Governing Board. Effective April 12, one seat will become vacant due to the resignation of Kim Khatibi.

Applicants must be Arizona registered voters and residents of the school district for at least one year prior to the date of appointment. Applicants or their spouses can’t be an employee of the district.

Application information:

  • Download the application here http://www.coconino.az.gov/schoolboardapplication
  • Deadline to submit is 5 p.m., Thursday, April 27.
  • Submit by email kgraves@coconino.az.gov (Live signature original required)
  • Submit by fax 928-526-1469 (Live signature original required)
  • Mail/drop off Coconino County School Superintendent, 2384 N. Steves Blvd, Flagstaff, AZ 86004

An advisory committee, consisting of district residents and a current board member will be assembled to conduct interviews and advise Superintendent VanderWey on the appointment. Appointment term will end on Dec. 31, 2018.

For more information, please call Kim Graves at the Office of the Coconino County School Superintendent at 928 679-8070 or e-mail: kgraves@coconino.az.gov.