Monthly Archives: October 2016

Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters

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On September 16, 2016, Vascular Solutions, Inc., initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Twin-Pass dual access catheters should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.

The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. 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 15,896 devices have been manufactured, with 5,784 distributed in the United States and currently unexpired. The condition that led to the recall may affect approximately 9.2% of recalled devices.

Vascular Solutions, Inc. voluntarily initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific unexpired 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 Online at http://www.fda.gov/medwatch/report.htm (form available to fax (1-800-FDA-0178) or mail), or you may call the FDA at 1-800-FDA-1088 to request a reporting form.

2017 Heritage Fund Grants request due October 31

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heritage-fundThe Oct. 31 deadline to submit applications for more than $400,000 in Heritage Fund grants is quickly approaching.

Grants will be awarded based on a competitive application process in the following categories: environmental education, outdoor education, schoolyard habitat, urban wildlife/habitat, public access, and Identification, Inventory, Acquisition, Protection and Management (IIAPM). This year 501(c) non-profit organizations can apply for grant funds without the need of a sponsor.

Heritage Fund grant background
The Heritage Fund was created after voters approved an initiative in 1990 and is funded through Arizona Lottery ticket sales. Heritage funding goes toward conservation efforts such as protecting endangered species, educating students and the general public about wildlife and the outdoors, and creating new opportunities for outdoor recreation.

The grant program was established by the Arizona Game and Fish Department in 1992 as part of the overall Heritage Fund program. The grants were initially developed as a way to promote outreach to enhance important partnerships and generate fresh approaches in support of the department’s mission.

Since the grant program’s inception, the department has awarded more than $14 million and supported more than 700 projects throughout the state.

Project requirements and how to apply
Potential grant recipients must have a project that is either located in Arizona or involves research in which the wildlife or its habitat is located in the state.

Applicants should refer to the documents on the Heritage Grant web page for guidance on applying. The documents include the Heritage Grant Application Manual, the Heritage Grant Application Form and the various “Heritage Grant Funding Window” documents, which describe eligibility information and provide specific eligibility criteria listed within each grant sub-category.

Proposals/applications for these grants can be submitted either by e-mail to rbeck@azgfd.gov or mailed to Arizona Game and Fish Department, Attn: Wildlife Grant Administrator, 5000 W. Carefree Highway, Phoenix, AZ 85086. No faxed applications will be accepted.

Applicants can submit grant applications up until the application deadline of 5 p.m. (MST) Monday, Oct. 31, 2016.

Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers

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lunch-1WASHINGTON D.C. — Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat and soy, known allergens, which are not declared on the product label.

The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:

3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.

The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
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The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.

The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

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

Consumers who have purchased this product are urged not to consume it. This product should be thrown away or returned to the place of purchase.

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. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact the Kraft Heinz Consumer Relations Center, at 1-800-573-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.com.

Extra trout stockings in White Mountains lakes to provide great fall fishing

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white-mountain-fishingPINETOP — The Arizona Game and Fish Department (AZGFD) has recently stocked thousands of catchable size rainbow trout into many of the White Mountain lakes. This gives anglers an extra incentive to get out to the lakes this fall.

Show Low Lake was stocked with 4,000 rainbow trout. Bear Canyon and Willow Springs Lake received 5,000 fish each. Another 7,000 trout went into Woods Canyon Lake. Fool Hollow Lake and River Reservoir each received 8,000 trout.

The AZGFD hatcheries had a surplus of fish that needed to be stocked into lakes to make room for next year’s trout. These fish were all stocked within the last 2 weeks, and the fishing should be great—especially with the cooler temperatures of fall.

This time of year, try fishing for rainbow trout using green, garlic scented PowerBait or worms. Tiger trout were also stocked for the first time in Arizona this year into Willow Springs and Woods Canyon lakes. Catch tiger trout using lures—they are more aggressive than rainbow trout. Bear Canyon Lake is a hike-in-only lake, but worth the short, steep hike. All others are easily accessible.

Happy 20th anniversary to Arizona’s endangered black-footed ferrets

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ferretPHOENIX — Arizona’s endangered black-footed ferret population celebrated the 20th anniversary of its reintroduction to Arizona with the release of more animals into a new privately-owned reintroduction area. Through a new Safe Harbor Agreement, the Double O Ranch outside of Seligman yesterday became the third reintroduction site in Arizona.

‘This release was made possible by a Safe Harbor Agreement, a newer conservation option that aims to enlist the help of non-federal landowners to conserve species. We hope our new partnership with the Double O Ranch will lead to the establishment of Arizona’s third population and contribute to national recovery goals,” said Jennifer Cordova, the Arizona Game and Fish Department’s black-footed ferret program supervisor.

The species was thought to be extinct until a small colony of ferrets was discovered in Wyoming in 1981. Disease outbreaks reduced this population to about 18 individuals, which were captured to begin a captive breeding program to save the species. Before reintroduction, the last black-footed ferret in Arizona was found in 1931 in an area between Williams and Flagstaff.

The descendants of the original 18 ferrets have now been introduced into reintroduction sites across the west, including the Aubrey Valley outside of Seligman, Ariz. In 2008, Aubrey Valley was declared a successful reintroduction site by the U.S. Fish and Wildlife Service as the population had become self-sustaining and no longer required augmentation.

Today, biologists estimate there are a minimum of 800 to 1,000 individual ferrets living in the wild.

While they resemble domestic pet ferrets, black-footed ferrets are a different species and are the only ferret native to North America. They can grow to be up to 2 feet long and can weigh up to 2 ½ pounds. One ferret can give birth to three to five kits each year.

The Arizona black-footed ferret reintroduction program is a joint effort of the Arizona Game and Fish Department, U.S. Fish and Wildlife Service, the Phoenix Zoo, U.S.D.A. APHIS Wildlife Services, Hualapai Nation, Navajo Nation, Arizona State Land Department, Babbitt Ranches and the Cholla Cattle Company.

ADOT internships prepare next generation of transportation professionals

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adot-intern-yuri-lechuga-robles_cropPHOENIX — Arizona’s network of highways requires transportation professionals specializing in areas as wide-ranging as planning routes, repairing bridges and creating beautiful landscaping along roadways.

To help ready the next generation of professionals to plan, operate and maintain a safe and efficient transportation system, the Arizona Department of Transportation employs nearly 40 interns whose work touches projects in every corner of the state.

Coming from communities across Arizona, the interns work in fields including engineering, urban planning, construction management, environmental science, landscape architecture and more.

Earlier this year, ADOT partnered with Arizona State University to have meteorology interns provide real-time forecasts to those managing highways. Working out of ADOT’s Traffic Operations Center, these interns have helped crews respond rapidly to storms and other weather challenges.

ADOT recruits interns from high schools and colleges every spring, and interns can work for the agency throughout their college careers and up to six months after graduating. Typically working one day a week, they tackle the same kinds of projects they’ll face after graduating.

Interns benefit from the experience of working with a supervisor plus a designated mentor.

“The interns I talk to love the program,” said Candee Samora, ADOT’s intern project coordinator. “They say they love school but there’s nothing that can replace the hands-on training they’re getting at ADOT.”

One of ADOT’s interns is Yuri Lechuga-Robles (shown in the photo), an Arizona State University landscape architecture student who graduated in May as the 2016 Outstanding Undergraduate Student for the Herberger Institute for Design and the Arts. Lechuga-Robles’ position in roadside development has allowed him to work on freeway projects in northern Arizona, Tucson and the Phoenix area. One of the lasting impacts of his work with ADOT Roadside Development is helping choose plants to go along roads and the graphic designs on bridges.

“Everyone in Roadside Development has been very helpful,” he said. “They’ve really taken care not to hold back and they’ve put me in situations where I can do things and learn. They’ve had confidence in me.”

Lechuga-Robles received the John E. McGee Intern Scholarship in 2015 from ADOT and the Western Association of State Highway and Transportation Officials. He was the first landscape architecture student awarded the scholarship named after McGee, the late ADOT chief financial officer.

“A lot of what I’m doing at school is directly related to the projects I do here,” Lechuga-Robles said. “It’s definitely been enriching to my career in landscape architecture.”

LeRoy Brady, ADOT’s chief landscape architect, said the agency gets just as much out of the experience as its interns do.

“Interns help us meet our project development goals and schedules,” Brady said. “They bring in new ideas and new ways of looking at things.”

For more information on ADOT internships, visit azdot.gov/internships.

Deadline to apply for 2017 spring hunt permit-tags is Tuesday, Oct. 11

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PHOENIX — Time is running out to apply for 2017 hunt permit-tags issued through the draw process for spring turkey, javelina, bison and bear.

To apply online, visit https://draw.azgfd.gov/ and scroll down to “Apply for a Draw.”

The deadline by which the Arizona Game and Fish Department must receive all applications – online or paper – is 11:59 p.m. (MST) Tuesday, Oct. 11. Postmarks do not count. Paper applications can be dropped off at the department’s headquarters in Phoenix or any regional office statewide.

As a reminder, all Game and Fish offices will be closed Monday, Oct. 10, in observance of Columbus Day. Offices will be open from 8 a.m. to 5 p.m. on deadline day, Tuesday, Oct. 11, but applications still will be accepted until 11:59 p.m.

The “2017 Spring Turkey, Javelina, Bison and Bear Hunt Draw Information” booklet is available online at www.azgfd.gov/draw. Printed booklets are available at all Game and Fish offices and license dealers statewide.

As a reminder, applicants must possess a valid Arizona hunting license to apply online for a hunt permit-tag. That license must be valid on the last day of the application period (Oct. 11). Licenses now are valid for one full year from date of purchase. Licenses are available online, as well as all Game and Fish offices and license dealers statewide.

For more information, visit www.azgfd.gov/draw, or call (602) 942-3000.

Meanwhile, PointGuard is available to applicants who apply online for a hunt permit-tag. PointGuard, the newest benefit for AZGFD Portal customers, ensures that if a successful applicant is unable to participate in a hunt for any reason, the accumulated bonus points that were expended to draw that hunt permit-tag will be reinstated.

All applicants must sign up for a free AZGFD Portal account to purchase PointGuard (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). PointGuard is $5 per species, per applicant, purchased at the time of completing the online application, or prior to the application period deadline.

Kaibab National Forest prescribed fire projects to begin south of Williams

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WILLIAMS —Fire managers with the Williams Ranger District of the Kaibab National Forest plan to conduct two prescribed fire projects south of Williams beginning Monday, Oct. 10, and continuing through next week.

The first of the two prescribed fire projects to be implemented will be the McCracken East Project, which is located east of County Road 73 near Barney Knoll 6 miles south of Williams. About 839 acres are scheduled to be treated using hand ignition with drip torches over two days. Smoke from the McCracken East Project is likely to be noticeable near Dogtown Lake, Sherwood Forest Estates, Pittman Valley, Parks, and Bellemont. While major smoke impacts are not anticipated in Williams, it is possible that smoke will be visible from the community and from Interstate 40.

If conditions remain favorable following completion of the McCracken East Project, fire managers will move slightly west to treat about 1,693 acres in the McCracken West Project, which is located just west of County Road 73 in the vicinity of Ham Tank and Kunde Knoll 7 miles south of Williams. Smoke impacts from the McCracken West Project are expected to be similar to those of McCracken East. Fire managers plan to use a helicopter to complete aerial ignitions on the burn unit over two days.

Kaibab National Forest fire managers have a number of other prescribed fires planned for fall and winter depending on fuel moistures and weather conditions. Following implementation of the McCracken projects, they will consider other locations on the Williams Ranger District to complete similar fuels reduction efforts. Public notification will be provided prior to the implementation of additional projects.

Fire plays a beneficial role in maintaining the ecological stability of many landscapes, including the Kaibab National Forest. Managers use prescribed fire as a practical means to reduce risks associated with uncharacteristic wildfires that can pose significant threats to public health and safety.

Forest managers recognize that prescribed fires may create negative impacts to air quality at times. However, these efforts, which are essential to restoring forests in a fire-adapted ecosystem, can also significantly reduce the amount and limit the duration of smoke impacts associated with uncontrolled wildfire situations in the future. In order to minimize smoke impacts to businesses and residences during prescribed fires, managers closely monitor wind direction and ventilation and adjust operations accordingly.

In the interest of safety, forest visitors are reminded to obey all traffic signs and use caution when traveling in the vicinity of prescribed fires as firefighters and fire-related traffic will be present.

All prescribed fires on the Kaibab National Forest are subject to approval by the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division and to view prescribed burn authorizations for any given day, visit https://www.azdeq.gov/programs/air-quality-programs/smoke-management.

Additional fire information for the Kaibab National Forest can be obtained through the following sources: InciWeb http://inciweb.nwcg.gov/incident/4112/#; Kaibab National Forest Fire Information Phone Line (928) 635-8311; Text Massage – text ‘follow kaibabnf’ to 40404.

To lead ADOT’s continuous improvement, director tries out different jobs

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director-gemba1_cropPHOENIX — Leave it to the new person to mess up the first time he tries applying reflective vinyl to make a road sign.

It seems so simple as he approaches the sign-making machine: Just slide a piece of polished aluminum under a roll of vinyl, press a pedal to start applying and … Jam.

“What did I do?” he says as his understanding supervisor swoops in to free the metal, cut through the bunched-up vinyl and clear the machine for another try.

Rookie mistake. The new person tapped the pedal too early, and this particular sign is history.

It turns out that mistakes are common as new hires learn the ropes in the Arizona Department of Transportation’s sign shop. That’s just one of the lessons ADOT Director John Halikowski will take away from his time today making and then installing road signs.

The sign operation may not have been as efficient as usual with the agency’s director temporarily on the team, but the visit will pay dividends for ADOT as a whole. This is a Gemba Walk, a continuous-improvement technique whose name comes from a Japanese term meaning going where work is done.

Gemba Walks allow leaders to not only better understand how work is performed but make employees part of examining roles and processes. Answering Governor Doug Ducey’s call for agencies to continuously improve their value to the state, this is something all ADOT leaders do, starting with the person atop the organizational chart.

After mastering the art of applying reflective vinyl, Halikowski learned how to apply red vinyl to turn his creation into a wrong-way sign. Then it was off to Interstate 10 and Avondale Boulevard with a crew to install larger wrong-way signs at that interchange.

Halikowski’s work in this phase of the Gemba Walk included placing traffic cones for safety and helping remove and hang signs. Describing the day as hot would be an understatement, and the director, clad in reflective garb and a hard hat, left with a greater appreciation of both sides of the sign operation and those who do the work.

“It was very different from what I normally do,” Halikowski said. “Everybody’s job is important and has meaning. I don’t care where you sit at ADOT, you contribute.”

His experience is now a video allowing all of ADOT to share in this Gemba Walk, with Halikowski interviewing employees and sharing what he learned, mistakes and all.

Looking at the camera as he ends his time with the sign crew along I-10, Halikowski offers some quick takeaways, starting with the importance of teamwork.

“You have to work together, you have to respect each other,” Halikowski says. “And you’ve really got to look out for your surroundings and safety.”

As part of its commitment to continuous improvement, ADOT is working to lower wait times at Motor Vehicle Division offices, reduce congestion on Phoenix-area freeways and increase the percentage of construction projects delivered on time, among other agency-wide goals. But every process in every department is part of this effort, and better understanding and analyzing the nature of work performed is essential for improvement to happen.

His day with ADOT’s sign operation was first of what will be many Gemba Walks for Halikowski, who says he hopes to instill the idea that no improvement is too small to make.

“People think of continuous improvement as this big thing, but most of these important improvements are easy to do in the workplace,” Halikowski said.

North Zone fire managers plan for additional treatments ahead

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FREDONIA — In the last two weeks, firefighters from the National Park Service and the U.S. Forest Service have worked together as the North Zone Interagency Fire Management Program to successfully complete more than 4,000 acres of hazardous fuels reduction treatments on the North Kaibab Ranger District of the Kaibab National Forest. This week fire managers continue to track conditions for additional treatments within the Kaibab Plateau.

These hazardous fuels reduction treatments may start as early as Thursday beginning with the Jacob Ryan Lobo Unit if weather and fuel conditions remain favorable and extend into prescribed fire operations on the Tipover East Unit.

Jacob Ryan Lobo Unit (Lobo Rx): The unit is 1,952 acres and is bound by a series of dozer lines connecting Forest Service Road (FS) 248G, FS 636A, FS 636, FS 248, and FS 247 on the north, FS 248V to FS 248 to FS 248A on the south, FS 247 on the east, and FS 248A on the west.

Fuels within the Lobo prescribed fire burn unit are predominantly ponderosa pine, pinyon pine, juniper and a few scattered clumps of aspen. New Mexico locust and cliff rose can also be found throughout the project area, and goals include protecting human life and improvements, expediting the development of Northern goshawk habitat, increasing resilience to insects, disease and wildfire, and increasing the overall forest health and sustainability by returning fire to a fire-adapted ecosystem.

Tipover East Unit (Tipover East Rx): The total Tipover East project area is 10,296 acres in size, but the entire project area will not be burned at once. Fire managers have divided the project area into separate burn units that will be treated over the next three to five years. They are focusing on approximately 3,500 acres for this season. The total unit covers a strip of forested land along the boundary of Grand Canyon National Park and the Kaibab National Forest west of Highway 67 and is bound by FS 223 on the north, portions of FS 270 and Highway 67 on the east, the 2003 Poplar fire history area on the south, and portions of the NPS-W4, FS 268B and FS 268 roads on the west.

Fuels within the Tipover East prescribed fire burn unit are primarily a mixed conifer forest with occasional patches of spruce-fir forest, aspen forest, ponderosa pine forest, and grasslands. Fuel loading through much of the unit can be characterized as moderate to heavy, approximately 36 to 55 tons per acre with an average of about 40 tons per acre across the entire unit. One objective within the Tipover East burn unit is to reduce these dead and downed woody fuels by 30 to 60 percent.

In the interest of safety, forest visitors are reminded to obey all traffic signs and use caution when traveling in the vicinity of the prescribed fire burn units as firefighters and fire-related traffic will be in the area. Smoke is expected to be visible from Highway 89A, Highway 67, Marble Canyon and other high-use visitor areas; however, fire managers will strive to minimize smoke impacts to the community as much as possible. Smoke is expected to disperse during the daytime, but residual smoke may settle into drainages and low-lying areas overnight. However, it is expected to dissipate quickly as fire managers will only commence ignitions when conditions exist that will allow smoke to adequately ventilate.

As a reminder, implementation of prescribed fires is dependent on weather and fuel conditions including winds, temperature, humidity, moisture of the vegetation and ventilation conditions for dispersal of smoke, as well as prior coordination with the Arizona Department of Environmental Quality. For additional information on the Smoke Management Division of the ADEQ and to view prescribed burns authorized on any given day, please visit www.azdeq.gov/environ/air/smoke/index.html.

Notifications of upcoming prescribed burns will be provided regularly throughout the season. Additional information on current and upcoming North Kaibab Ranger District prescribed burns are provided through the following methods:

· Fire Information Recorded Hotline: 928-635-8311
· Twitter: www.twitter.com/KaibabNF (Text ‘follow kaibabnf’ to 40404 to receive text messages.)
· Kaibab website “News & Events”: www.fs.usda.gov/kaibab
· InciWeb: inciweb.nwcg.gov/incident/5021/