Monthly Archives: April 2016

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).

When it comes to driving in work zones, ‘The Vest Knows Best’

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PHOENIX — Flashing orange lights. Bright orange traffic cones. Striped barrels and barricades.

You’re entering a work zone.

What coincidental timing, too, because the Arizona Department of Transportation is marking the beginning of National Work Zone Awareness Week (April 11-15) today.

After slowing and merging near the start of the work zone, there’s the flagger with a stop/slow paddle and a fluorescent reflective vest strapped across his chest. Expertly moving traffic safely through the work zone all day, obey this person’s instructions – as ADOT’s work zone safety message declares, “The Vest Knows Best” – because lives, including yours, depend on it.

Up ahead, see that maintenance crew? The highway is their office, so please slow down and focus on the road. This ensures a safe work space for them and keeps you safe, too. That’s especially important because, statistically, motorists are far more likely to die in a work zone crash.

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. In Arizona, the number of work zone deaths fell to 11 in 2014 after peaking at 17 in 2013. Despite this decrease in work zone fatalities, there is room for improvement

To achieve that, in conjunction with National Work Zone Awareness Week, ADOT is launching a work zone safety campaign, “The Vest Knows Best,” to protect motorists and those who build and maintain Arizona’s highways. Follow these tips when traveling through a work zone to keep everyone safe.

• 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.

Phoenix to host second public hearing for ADOT’s Tentative Five-Year Program

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PHOENIX — The Arizona Department of Transportation continues to gather comments for its proposed five-year construction program by reaching out to the public and communities statewide for their input on which projects should move forward over the next few years.

The second public hearing for the 2017-2021 Tentative Five-Year Transportation Facilities Construction Program is scheduled for 9 a.m. Friday, April 15, at the ADOT Administration Building Auditorium, 206 S. 17th Ave. in Phoenix. The monthly State Transportation Board meeting will follow the public hearing.

For this Tentative Five-Year Program, ADOT was able to recommend a few more expansion projects for Greater Arizona because of additional funding through the federal Fixing America’s Surface Transportation Act, as well as a Transportation Investment Generating Economic Recovery (TIGER) grant. These projects, aimed at enhancing key freight corridors in Arizona, otherwise would have remained in ADOT’s Development Program as projects not starting until six to 10 years out.

Among ADOT’s suggestions to move forward on a quicker timeline are two Interstate 10 widening projects in Pinal County (segments at State Route 87 to Picacho Peak and Earley Road to Interstate 8), two widening projects along US 93 and the State Route 347 railroad overpass project in the city of Maricopa. The SR 347 project received a $15 million TIGER grant and a $15 million local contribution to add to ADOT’s $19 million commitment.

Facing growing statewide needs and limited transportation funding from traditional sources, ADOT remains committed to preserving the existing state highway system, which is valued at more than $20 billion. ADOT’s proposal meets its goal of $260 million per year dedicated to preservation work, such as bridges in need of upgrades and pavement in need of repair.

The 2017-2021 Tentative Program is available for public review and comment at azdot.gov/fiveyearplan, where a “how to read it” guide is available. ADOT welcomes feedback through Survey Monkey at surveymonkey.com/r/CJY36HY, email at fiveyearconstructionprogram@azdot.gov and by calling 1-855-712-8530. The comment period ends at 5 p.m. on May 30.

The public comment period includes three public hearings around the state. The State Transportation Board will then make its decision in June about what will be in the final 2017-2021 Five-Year Program.

Here are details for the two remaining public hearings and the State Transportation Board’s June meeting. The first public hearing was held in Oro Valley last month.

  • April 15 at 9 a.m.: Public hearing and board meeting in the ADOT Administration Building Auditorium, 206 S. 17th Ave., Phoenix.
  • May 20 at 9 a.m.: Public hearing and board meeting in the City of Flagstaff Council Chambers, 211 W. Aspen Ave., Flagstaff.
  • June 17 at 9 a.m.: Board meeting in the City of Holbrook Council Chambers, 465 First Ave., Holbrook

Intermittent closures scheduled for bridge work on SR 89 at Hell Canyon

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Crews are expected to work on the bridge structure on State Route 89 at Hell Canyon (mileposts 345 to 346) that will require intermittent closures of up to 10 minutes at a time starting on Tuesday (April 12) through Thursday (April 14) between 9 a.m. and 3 p.m.

Traffic will be guided through the work zone with flaggers as SR 89 will be reduced to one lane on the bridge.

ADOT advises drivers to proceed through the work zones with caution, slow down, and be alert for construction equipment and personnel.

ADOT works to inform the public about planned highway restrictions, but there is a possibility that unscheduled closures or restrictions may occur. Weather can also affect a project schedule. To stay up-to-date with the latest highway conditions around the state, visit the ADOT Traveler Information Center at www.az511.gov or call 511.

AZGFD to display world-record desert bighorn sheep

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PHOENIX — The most magnificent desert bighorn sheep in the world now stands regal among the wildlife mounts on display at Arizona Game and Fish Department headquarters in Phoenix.

On loan from the Arizona Desert Bighorn Sheep Society, the massive ram joins the bull elk, pronghorn, black bear, mountain lion and more, including small game and several sportfish, in the customer service area for all to see.

Scrivens_Ram“This is the ideal place for this ram,” said Pete Cimellaro, whose organization delivered and assembled the mount in advance of this weekend’s meeting of the Arizona Game and Fish Commission. “It’s home. It’s just the epitome of what a desert bighorn sheep looks like – and a really, really big one.”

The backstory behind the “Scrivens” ram is almost as extraordinary as his immense horns that scored at 205-1/8 points when they were first measured unofficially in 1946 by the Boone and Crockett Club – a world record that hasn’t been challenged for 70 years.

While on a hunting trip in 1942 on a remote ranch on Mexico’s Baja Peninsula, Carl Scrivens and his brothers were taking a stroll around the ranch when they spotted the skull and horns in the back of a dilapidated wagon. According to vaqueros at the ranch, the ram had been killed a year or so earlier by a Native American who was hunting for meat and left the head.

Scrivens_Ram_-_1The brothers, knowledgeable about the size of desert bighorn rams, were not about to leave without the head and acquired it for a mere eight pesos — and a wool sweater Scrivens was wearing at the time that caught the eye of a vaquero.

“That goes down with things like the Louisiana Purchase,” Cimellaro said, laughing.

The ram was bequeathed in 1992 to ADBSS, of which Scrivens had been a lifelong member. In fact, he and his wife, Anna, often would come from their home in Afton, Wyo., to help with water catchment projects.

“They loved the desert,” Cimellaro said. “They shared many campfires with members of the sheep society. That affinity is what gave Carl the idea to allow us to be custodians of the ram. He said, ‘This is the perfect place because the sheep society is always going to care about sheep.’ ”

After obtaining a suitable cape for the ram from Game and Fish, the restored mount was put on display in 1992 at the Boone and Crockett Club’s National Collection of Heads and Horns at the Buffalo Bill Historical Center in Cody, Wyo. In recent years, the mount had found its way to the headquarters of Bass Pro Shops in Springfield, Mo. It was Cimellaro who recently made the trip back to Missouri, crated the world-record ram and brought it back to Arizona.

Cimellaro still marvels at the size of its thick, heavy horns.

“Nothing really has approached it,” Cimellaro said. “That might change someday, who knows? At this time, it’s one of the longest-standing records out there.”

Game and Fish headquarters is located at 5000 W. Carefree Highway, Phoenix, 85086. Hours are 8 a.m. to 5 p.m. weekdays, except for holidays. For more information, visit www.azgfd.gov, or call (602) 942-3000.

Recycle bins rejoice: Innovation moves ADOT bid process from paper to PDF

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PHOENIX — Who says doing business with a government agency has to involve lots and lots and lots of paper?

Thanks to improvements to how the Arizona Department of Transportation presents project opportunities online, contractors’ recycle bins are getting lighter. Those interested in bidding for projects now can simply determine which projects they want to pursue and download related documents.

It replaces a process that was more than a little heavy on paper, requiring contractors to drive to ADOT and pay for copies of construction plans and specifications. For example, bidders hoping to work on a six-mile section of Loop 303 several years ago hauled away more than 1,700 pages of plans.

“This is another example of our commitment using the latest technology to continuously improve processes and create better experiences for our customers,” ADOT Director John Halikowski said.

The improvement is saving both ADOT and contractors time and money. While contractors had paid a fee to help cover ADOT’s printing costs, the agency often wound up with more stacks of plans than bidders.

For contractors, the innovation also eliminates the need to scan 24-by-36-inch plan sheets. This saves time and effort, making it easier to do business with ADOT ‒ and to do business in general.

“The benefits are numerous, from the simple ability to look at plans quickly and assess whether the job is a fit without having to have plans mailed or have a runner go down to pick them up,” said Carlos Gonzalez, executive vice president of Rummel Construction, a member of the Arizona chapter of the Associated General Contractors of America. “It makes it easier for general contractors to get plans distributed to subcontractors, allowing more time to develop comprehensive bids.”

The new system, available at azdot.gov/business (see Contracts and Specifications > Current Advertisements), went live in February with the help of ADOT Contracts and Specifications and Information Technology Group team members. In addition to including a variety of plan documents and other important information, the site allows contractors to receive automatic notifications of any project changes.

Steve Boschen, director of ADOT’s Infrastructure Delivery and Operations Division, said that while ADOT is still determining exactly how much the improved process will save the state in direct printing and labor costs, it’s already providing better customer service to Arizona contractors and subcontractors.

“We’re excited to have a new process that will make it easier for contractors to do business with ADOT,” he said.

ADOT equipment shops recognized for reducing environmental impact

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PHOENIX — The Tucson facility where the Arizona Department of Transportation repairs and maintains its vehicles has significantly reduced the amount of trash it generates by recycling scrap metal, batteries, automotive fluids, paper and more. Converting to LED lighting has reduced energy use.

Along with ADOT’s repair facility in Springerville, the Tucson operation has been recognized through the agency’s Green Shop program, which seeks to minimize environmental impact, cut waste and increase recycling at 22 ADOT Equipment Services locations.

“We’re reducing the cost to the state because we’re keeping waste down,” said Nathan Carroll, the fuel, scales, environmental and training manager for ADOT Equipment Services. “The end result is increasing productivity. For the taxpayer, that’s a good thing.”

The Green Shop program began in 2006 with a best-practices manual offering guidelines on subjects including keeping shops clean and organized for efficient operations and properly containing spills. It has become an important part of daily operations at all ADOT service shops.

More than 40 government agencies contract with ADOT Equipment Services, including the Arizona Game and Fish Department, Arizona Department of Public Safety, police departments and school districts. The shops perform preventive maintenance and major repairs on light trucks, snowplows, watercraft, snowmobiles, school buses and more.

Every two years, one full-service shop and one satellite location are honored following three inspections, one of which is unannounced, to see how operations are following the Green Shop guidelines.

An event to honor the Tucson operation was held April 8. An April 18 ceremony is scheduled at the Springerville facility.

Arizona Game and Fish Outdoor Expo draws record weekend crowd

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ExpoRecap_2016_bannerPHOENIX — The Arizona Game and Fish Department’s 2016 Outdoor Expo, presented by Shikar-Safari Club International, drew a record crowd of 41,100 people during the April 2-3 weekend at the Ben Avery Shooting Facility in Phoenix.

Combined with 4,500 students, teachers and chaperones who turned out for the Friday, April 1 Youth Day, the 45,600 total was the second-highest three-day turnout in Expo history.

We’re thrilled with the public’s interest in the Expo,” said Game and Fish Recreation Chief Scott Lavin. ”We hold this annual event to introduce or re-engage the public with the many wildlife-related and other outdoor recreation opportunities available in Arizona.”

The Expo showcases activities such as fishing, hunting, shooting sports, archery, camping, off-highway vehicle recreation, boating recreation, and wildlife viewing. In addition to the hands-on activities, more than 150 exhibitors were on site, including sportsmen’s and conservation organizations, government agencies, and commercial vendors of outdoor products and services.

“Despite a number of other high-profile events in the Valley over the weekend, the record Expo turnout shows there is huge interest in learning about the great outdoors,” said Lavin.

For the second straight year, the Presenting Sponsor of this year’s Arizona Game and Fish Department Outdoor Expo was Shikar-Safari Club International.

Gold Sponsors were Cabela’s, Arizona State Credit Union, and the National Shooting Sports Foundation. Silver Sponsors were Bass Pro Shops, Sportsman’s Warehouse, and HPR Ammunition. Bronze Sponsors were the Mule Deer Foundation and Bill Luke Dodge.

“We’re grateful for the support of Shikar-Safari Club International and all of our other sponsors and exhibitors,” said Game and Fish Director Larry Voyles. “Without their participation, we could not conduct an event such as this. They are helping pass along our outdoor heritage to current and future generations.”

The mission of the Arizona Game and Fish Department is to conserve Arizona’s diverse wildlife resources and manage for safe, compatible outdoor recreation opportunities for current and future generations. The department operates without receiving any Arizona general fund tax dollars. Outdoor Expo costs are paid for by sponsor and exhibitor fees.

Next year’s Outdoor Expo will be held March 25-26, 2017, at the Ben Avery Shooting Facility in Phoenix. More information will be posted at www.azgfd.gov/expo as it becomes available.