Daily Archives: April 11, 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