Category Archives: National

Datascope recalls certain Intra-Aortic Balloon pumps.

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Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

AFFECTED PRODUCT PART NUMBER
CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX
CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX
CS300 IABP 0998-00-3023-XX; 0998-UC-3023-XX

This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:

    WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.

  • Until the service is performed, we recommend powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

There are approximately 12,000 affected units sold globally. The affected IABP units were distributed in the U.S. and worldwide (in over 100 countries). Affected units were distributed between March 23, 2003, and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

For additional information regarding this field correction, please contact the Customer Service Department at 1-888-627-8383 and Press 2 (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).

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

  • 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.

Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

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Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.

This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death. The FDA has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide.

Abbott began contacting customers in March who received coronary catheters from the affected lots, and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.

Specific lots of affected product were manufactured between January 1, 2015 to January 2, 2017, and were distributed between January 13, 2015 to March 14, 2017. For more information, please see Abbott’s field safety notice.

For Important Safety Information on NC Trek Catheters see PDF.

National Park Service seeks public comment on initial environmental assessment for bison herd reduction at Grand Canyon

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PHOENIX – The National Park Service (NPS) has made available for public review its Initial Bison Herd Reduction Environmental Assessment (EA), which evaluates management actions related to bison on the Grand Canyon’s North Rim. The public can view the EA on the NPS website and submit any comments through June 7.

Since the 1990s, the bison population on the Kaibab Plateau herd has grown significantly, impacting Grand Canyon National Park resources such as water, vegetation, soils and archaeological sites. While they are negatively affecting habitat at their current numbers, bison can provide exceptional value to the visitor experience, when managed at appropriate numbers and distribution.

The purpose of the actions evaluated in the EA are to (1) quickly reduce bison population density on the Kaibab Plateau through collaborative efforts and (2) protect Grand Canyon National Park resources and values from the impacts of a steadily growing bison population.

According to a NPS news release, the NPS would work together with cooperating agencies and partners through the preferred alternative to reduce the bison herd to fewer than 200 animals using lethal culling with skilled volunteers and non-lethal capture and removal.

A management action that is not included in the Park Service’s preferred alternative is reducing the bison herd through public hunting. The Arizona Game and Fish Commission and Department have consistently advocated for a model that uses properly licensed hunters as a management tool and allows the hunter to keep the animal.

“Several of the proposed actions in the Park Service EA will cost taxpayers far more than lethal removal by citizen hunters who would pay for the opportunity to assist the NPS,” said Arizona Game and Fish Commissioner Kurt Davis. “This will provide additional hunting opportunities consistent with the North American Model of Wildlife Conservation and help to properly manage the bison population. This approach just makes sense and supports efforts to alleviate park damage caused by bison, saves tax dollars, funds wildlife conservation and helps protect habitat for other wildlife.”

The NPS will host three in-person open house meetings and one web-based meeting during the comment period. All times are Arizona time (Mountain Standard Time – MST) unless otherwise indicated:

  • 6 p.m. – 8 pm. Tuesday, May 16 at the DoubleTree by Hilton, 1175 W. Route 66 in Flagstaff.
  • 5 p.m. – 7 p.m. Thursday, May 18 at the Ben Avery Activity Center, 4044 W. Black Canyon Blvd in Phoenix.
  • 6 p.m. – 8 p.m. (Mountain Time) (5 p.m. – 7 p.m. Arizona time) Tuesday, May 23 at the Holiday Inn Express and Hotel, 217 S. 100 East in Kanab, Utah.
  • 5 p.m. – 6 p.m. Tuesday, May 30 online. Registration for the web-based meeting and more information about the open houses can be found here.

Comments can be submitted either electronically or via U.S. Postal Service at Grand Canyon National Park, P.O. Box 129, Attn: Bison Management Plan EA, Grand Canyon, AZ 86023 or at one of the in-person public meetings listed above.

Comments must be received by June 7. Comments will not be accepted by fax, email or by any method other than those specified above. Bulk comments in any format (hard copy or electronic) submitted on behalf of others will not be accepted.

Valley Innovative Services Recalls Meat and Poultry Frozen Entrée Products Due to Possible Listeria Contamination

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WASHINGTON – Valley Innovative Services, a Pearl, Miss. establishment, is recalling approximately 130,071 pounds of meat and poultry frozen entrée products which included a non-meat ingredient (waffles) that was recalled due to Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The heat-treated, not fully cooked, not shelf stable chicken and waffle, turkey ham & waffle, and oatmeal with waffle and sausage patty frozen entrée items were produced and packaged from May 2016 through May 2017. The following products are subject to recall: [View Labels (PDF Only)]

  • 11.40-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Four Seasons Vegetables and Cabbage” with the following production dates: 6/6/2016, 7/13/2016, 8/15/2016, 10/12/2016, 12/21/2016 and 4/11/2017; and the following sell-by dates: 6/6/2017, 7/13/2017, 8/15/2017, 10/12/2017, 12/21/2017 and 4/11/2018.
  • 11.35-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Rib Meat with Cinnamon Flavored Sweet Potatoes and Seasoned Green Beans” with the following production dates: 10/12/2016, 11/18/2016, 12/21/2016, 1/26/2017, 1/30/2017 and 3/1/2017; and the following sell-by dates: 10/12/2017, 11/18/2017, 12/21/2017, 1/26/2018, 1/30/2018 and 3/1/2018.
  • 12-oz three compartment tray packages containing “Traditions Creamy Chicken Patty & Waffle with Cinnamon Flavored Sweet Potatoes and Four Seasons Vegetables” with the following production dates: 12/9/2016, 12/21/2016, 1/26/2017 and 1/30/2017; and the following sell-by dates: 12/9/2017, 12/21/2017, 1/26/2018 and 1/30/2018.
  • 9.20-oz three compartment tray packages containing “Traditions Turkey Ham & Waffle Cured Turkey Thigh meat Chunked and Formed with Fruit Cocktail and Hash Brown” with the following production dates: 12/12/2016, 1/21/2017, 1/30/2017, 3/16/2017, 3/21/2017, 4/3/2017, 4/5/2017, 4/18/2017, 4/26/2017; and the following sell-by dates: 12/12/2017, 1/21/2018, 1/30/2018, 3/16/2018, 3/21/2018, 4/3/2018, 4/5/2018, 4/18/2018, 4/26/2018.
  • 7.40-oz three compartment tray packages containing “Traditions Oatmeal with Waffle and Sausage Patty” with a production date of 10/14/2016 and a sell-by date of 10/14/2017.

The products subject to recall bear establishment number “EST. 18350” on the packaging label. These items were shipped to institutions nationwide.

The problem was discovered when Valley Innovative Services was notified by their waffle supplier that the waffle product used in the frozen entrée products was recalled due to potential Lm contamination. There have been no confirmed reports of adverse reactions due to consumption of these products.

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

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. Consumers with questions regarding the recall can contact Jonathan Palmer, Customer Service Representative, at (601) 420-8847. Members of the media with questions regarding the recall can contact Brittany Mayer-Schuler, Vice President for Legal Affairs/General Counsel, at (866) 721-7859.

Green Chile Food Company Recalls Meat and Poultry Burrito Products Due to Possible Listeria Contamination

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WASHINGTON – Green Chile Food Company, a Las Cruces, N.M. establishment, is recalling approximately 252,854 pounds of ready-to-eat (RTE) meat and poultry frozen burrito products because they may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.The ready-to-eat meat and poultry frozen burrito items were produced and packaged on various dates between March 8, 2017 and May 10, 2017. The following products are subject to recall:

  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, EGG & BACON BURRITO with Cheddar Cheese, Potato, Green Chile, Salsa & Jalapeños” with case code of 833425000900.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, POBLANO CHICKEN BURRITO with Monterrey Jack Cheese, Salsa, Rice, Onion, Green Chile and Green & Red Bell Peppers” with case code of 833425000931.
  • 8-oz paper wrap packages containing “am pm & Green Chile FOOD COMPANY, BEEF & POTATO BURRITO with Cheddar Cheese, Green Chile & Salsa” with case code of 833425000887.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, Chipotle Chicken Burrito with Salsa & Monterey Jack” with case code of 833425001426.

  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CARNITAS Burrito with Salsa, Monterey Jack & Cilantro Lime Rice” with case code of 833425001488.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & SAUSAGE Breakfast Burrito with HASHBROWNS, Salsa, & Cheddar” with case code of 833425000382.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, EGG & BACON Breakfast Burrito with HASHBROWNS, Salsa, Green Chile & Cheddar” with case code of 833425000368.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF Burrito with POTATO, GREEN CHILE, Salsa & Cheddar” with case code of 833425000320.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, CHICKEN FAJITA Burrito with Salsa & Cheddar” with case code of 833425000429.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, SHREDDED STEAK Burrito with Salsa, Monterey Jack, Green Chile, Onion, Rice & Jalapeño Peppers” with case code of 10833425008941.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, BEEF & BEAN Burrito with Green Chile, Salsa & Cheddar” with case code of 833425000344.
  • 7-oz paper wrap packages containing “Green Chile FOOD COMPANY, FIESTA Breakfast Burrito with Beef, Egg, HASHBROWNS, GREEN CHILE, Cheddar & Sausage” with case code of 833425000405.

The products subject to recall bear establishment number “M-21740 or P-21740” inside the USDA mark of inspection. These items were shipped to institutions, retail stores and distribution centers in California, Illinois, Oregon, and South Dakota.

The problem was initially discovered by FSIS Inspection Program Personnel (IPP) during a routine Listeria monocytogenes product sample of beef and potato burrito. There have been no confirmed reports of illness due to consumption of these products.

Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.

Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.

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. Consumers with questions regarding the recall can contact Green Chile Concepts, Premiere Response Contact Center, at (800) 695-0843. Members of the media with questions regarding the recall can contact Greg Flack, CEO, at (952) 666-2995.

Lamb Weston Issues Allergy Alert on Undeclared Milk in Red Robin Burgers and Brews Crispy Onion Rings Sold in Grocery Stores

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Lamb Weston is recalling 14 ounce packages of Red Robin Burgers and Brews Crispy Onion Rings manufactured by Fry Foods and sold in grocery stores, because the product may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

These products are NOT served in Red Robin restaurants. The Red Robin Burgers and Brews Crispy Onion Rings were distributed in the U.S. through retail grocery stores. No other products are impacted by this recall.

The product comes in a 14 ounce bag and is frozen. Details on the impacted packages are listed below. The Sell By Date and Package Code can be found on the back of the package. The HH:MM portion of the Package Code indicates the time product was made and will vary by package. Please refer to the images of the packaging included for additional information.

UPC Product Name Net Weight Sell By Dates Package Code
0 43301 61119 3 Red Robin Crispy Onion Rings 14 Oz Sell By OCT 28 2018
Sell By OCT 29 2018		 6906711841 HH:MM
6906711941 HH:MM

No illnesses have been reported to date in connection with this product.

The recall was initiated after it was discovered that contract manufacturer Fry Foods mistakenly packed product containing milk in packaging that did not reveal the presence of milk. Subsequent investigation indicates the product did not meet Lamb Weston specifications.

Consumers who have purchased Red Robin Burgers and Brews Crispy Onion Rings from a grocery retailer are urged to return the product to the place of purchase for a full refund.

Fry Foods and Lamb Weston are cooperating with the FDA on this recall and working with customers to ensure packages are removed from store shelves and are no longer distributed.

Consumers with questions about this recall may contact 1-866-518-0137, Monday-Friday, from 9 a.m. – 6p.m. EDT.

Trident Seafoods Corporation Recalls Frozen Multi-Grain Alaskan Cod

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Trident Seafoods Corporation is issuing a voluntary recall of select lots of frozen Multi-Grain Alaskan Cod, Net Wt. 12, oz., because they may contain small pieces of plastic. Consumption of these products may pose a choking hazard or other physical injury to the mouth.

The following retail product is subject to the voluntary recall:

Trident Seafoods Multi-Grain Alaskan Cod (Frozen), Net Wt. 12oz., UPC 0 28029 21048 4

Recalled Lot Numbers with associated Best By dates are printed on one end of the individual retail cartons and on the case label.

• Lot Number A633511, Best By: 11/30/2018
• Lot Number A636225, Best By: 12/27/2018

Lot Number A633511 – Distributed between 12/1/2016 and 2/9/2017 to Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington, and Wisconsin

Lot Number A636225 – Distributed between 1/23/2017 and 2/17/2017 to Arizona, California, Colorado, Illinois, Kansas, Massachusetts, Texas, Washington, and Wisconsin

These products are sold at Albertsons, Amazon, Cub Foods, Jewel, Morey’s, Plaza Extra, Shaw’s, Shoprite, Sprouts, SUPERVALU, and Woodman’s retailers.

This issue was discovered through consumer feedback. The source of the white plastic has been identified as inspection tags used by an ingredient supplier. Trident Seafoods takes food safety very seriously and is investigating this situation thoroughly.

There have been no reports of injury or illness related to the recalled products to date, however 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. For additional information consumers can call Ms. Trev Foley, Consumer Affairs Manager, at 206-297-5825, Monday – Friday, 8 a.m. – 5 p.m. PST, or send email to trevf@tridentseafoods.com .

Northern Arizona federal land managers invite public to community conversation event

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FLAGSTAFF – Federal land managers with the Forest Service, National Park Service and Bureau of Land Management invite the public to attend a community conversation in May as part of an ongoing effort to connect with the public and hear first-hand what people value about their public lands.

In partnership with the Museum of Northern Arizona, this event will be held in Flagstaff in the Branigar Hall at the Museum of Northern Arizona from 6-8 p.m. on Thursday, May 25. Seating is limited to 60-70 people at this free community event, so please RSVP by calling (928) 774-5213 or visit www.musnaz.org.

The following federal land managers will be in attendance and look forward to interacting with the public:

– Coconino National Forest Supervisor Laura Jo West,
– Kaibab National Forest Supervisor Heather Provencio,
– Flagstaff Area National Monuments Superintendent Kayci Cook Collins,
– Grand Canyon National Park Superintendent Chris Lehnertz, and
– BLM Phoenix District Manager Leon Thomas.

Speakers will provide introductory remarks, move to “talking circles” to interact and have conversations with community members, and conclude by reporting out and providing closing remarks.

This is a chance for the public to meet face-to-face with the leaders of organizations that manage federal lands in northern Arizona. The public is invited to attend this special event and share their thoughts on what they value about public lands now and into the future.

U.S. Deer Antler EX. & IM., INC. Announces The Recall Of Herbal Tea Varieties In Pouches

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U.S. Deer Antler Ex. & Imp., of Los Angeles, CA is recalling a variety of Herbal Teas prepared on premises between 4/1/17 and 4/30/17 in cooperation with an inspection made by the California Department of Public Health. The aforementioned Herbal Teas, especially those with low-acidity held at room temperature, were not produced according to approved guideline, making them susceptible to contamination by Clostridium botulinum.

Below are the product descriptions and photographs:

Products Packaging Cases
Herbal Tea Variety Batches prepared on premise between 4/1/17 – 4/30/17 120 ml/ Pouch 40 Pouches / Case

The Herbal Teas were distributed to individual customers and acupuncturists in California, Florida, Illinois, Maryland, North Carolina, Texas, and Virginia.

Symptoms of Clostridium botulinum typically begin with blurred or double vision followed by trouble speaking, swallowing; and progression to muscle weakness starting in the upper body, moving downward.  Botulism can lead to life-threatening paralysis of breathing muscles requiring support with a breathing machine (ventilator) and intensive care. http://www.cdph.ca.gov/HealthInfo/discond/Pages/Botulism.aspx

People experiencing these symptoms who have recently consumed these Herbal Teas should seek immediate medical attention.

In its ongoing cooperation with the California Department of Public Health, U.S. Deer Antler Ex. & Imp., Inc. has immediately segregated its entire inventory of Herbal Tea varieties, and is notifying consumers and customers not to consume potentially-contaminated product. Furthermore, U.S. Deer Antler Ex. & Imp. Inc. is voluntarily recalling all varieties of general Herbal Teas prepared on-site in the period of 4/1/17 to 4/30/17 to ensure consumer safety.

Consumers in possession of these products are to stop consumption and return unconsumed product to their original place of purchase.

U.S. Deer Antler Ex. & Imp., Inc. will be sending recall notices to all of its direct customers.  Please contact Joong W. Park (323) 735-9665 for further information.

ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters

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WASHINGTON, D.C. – On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.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 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, and then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.