Month: February 2016

For Immediate Release

February 26, 2016

Contact

Consumers

Abbott Vascular Representative
or
Abbott
 1-800-227-9902

Media

Jonathon Hamilton
 (224) 667-8646

 

Announcement

Abbott has initiated a voluntary safety notice regarding the MitraClip® Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.

Abbott’s investigation determined that the delivery system’s “arm positioner” was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the Clip from detaching. All of these cases (0.17% incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem. There was one patient death in these cases as a result of severe comorbidities following surgery. (more…)

For Immediate Release

February 26, 2016

Contact

Consumers

Maytag Dairy Farms
 800-247-2458
 641-791-2010 Monday – Friday

Media

Ross Parman
 202-494-8195

Announcement

NEWTON, IOWA – Maytag Dairy Farms is expanding its voluntary recall of “Maytag Blue” blue cheese wedges, wheels and crumbles because they have the potential to be contaminated with Listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported in connection with this issue. (more…)

Class I Recall 021-2016
Health Risk: High Feb 25, 2016

Congressional and Public Affairs
Nina Anand
(202) 720-9113

 

WASHINGTON, Feb. 25, 2016 – Sally Sherman Foods, a Mount Vernon, N.Y. establishment, is recalling approximately 3,004 pounds of various chicken products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The chicken salad items were produced on various dates between Feb. 2-18, 2016. The following products are subject to recall: [View Labels (PDF Only)]

  • 4-lb. Plastic container of Sally Sherman “Spa Chicken Salad with Greek Yogurt,” with a packaging date of Feb. 2, 9, 11, and 18, 2016 and a case code of N-026, N-096, N-114, N-184.
  • 4-lb. Plastic container of Sally Sherman “Chicken Salad All White Meat,” with a packaging date of Feb. 2, 4, 11, and 18, 2016 and a case code of N-026, N-044, N-114, N184.
  • 4-lb. Plastic container of Sally Sherman “Deluxe Chicken Salad All White Meat,” with a packaging date of Feb. 4, 11, and 18, 2016 and a case code of N-044, N-114, N184.
  • 4-lb. Plastic container of Sally Sherman “Farmcrest Chicken Salad,” with a packaging date of Feb. 2, 4, 9, 11, and 18, 2016 and a case code of N-184, N-114, N-026, N-044, N-096.
  • 4-lb. Plastic container of Sally Sherman “Cranberry Walnut Chicken Salad,” with a packaging date of Feb. 4, 9, 11, and 18, 2016 and a case code of, N-044, N-096 N-114, and N-184.

The products subject to recall bear establishment number “P-4400” inside the USDA mark of inspection. These items were shipped to distributor locations in New York, New Jersey, Virginia, Pennsylvania, and Maryland.

The problem was discovered due to in-plant sampling of products that confirmed positive for Lm. FSIS and the company have received no reports of illness due to consumption of these products. (more…)

Recall Summary

Name of product: Gas boilers

Hazard:

The boiler can overheat and emit flue gases into the venting system and carbon monoxide can leak throughout the residence, posing a fire and carbon monoxide hazard to consumers.

Consumer Contact: Viessmann toll-free at 800-288-0667 from 8:30 a.m. to 5 p.m. ET Monday through Friday or online at www.viessmann-us.com and click on the “Important Safety Notice” located in the middle of the homepage for more information.

Report an Incident Involving this Product

Recall Details

In conjunction with

Health Canada Logo

Units

About 165 in the United States (in addition, about 141 were sold in Canada)

Description

This recall involves the Vitodens 200-W condensing gas boilers used for residential use. These wall hung units are housed in a white metal box that measures about 43.5 inches tall by 19 inches wide by 21 inches deep.  There are two models: B2HB-45 and B2HB-57 included in this recall.  The name “Vitodens” and “Viessmann” are printed on the label on the outside of the boiler box. The product name and model number can be found on the boiler rating plate located on the left side of the white boiler cover. The serial number can be found on a separate label under the boiler cover or on the left hand side of the unit. Recalled boilers do not have a blue dot with a handwritten data label on it.

 

The two models of boilers included in the recall have the following serial number ranges:

 

Product Name Model Numbers Serial Number Range
Vitodens 200-W

 

B2HB-45 7554703501001105 to 7554703501369106 *
B2HB-57 7554704501001102 to 7554703501411109 *

* Serial number range within bold number range are the only units included in the recall.

Incidents/Injuries

The firm has received 10 reports where the boilers overheated, causing the boilers to shut down. No injuries have been reported. (more…)

Class III Recall 020-2016
Feb 23, 2016

Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113

 

WASHINGTON, Feb. 23, 2016 – Ajinomoto Windsor Inc., a Portland, Ore. establishment, is recalling approximately 6,000 pounds of pork products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product is labeled as beef, but contains pork, which is not declared on the product label.

The pork dumpling item was produced on Dec. 6, 2015. The following product is subject to recall: [Label]

  • 4-lb. plastic bag packages of “Shirakiku Gyoza Dumplings with Beef” with a best if used by date of June 6, 2017.

The product subject to recall bears establishment number “Est. 18356” inside the USDA mark of inspection. This item was shipped to institutional and retail locations nationwide.

The problem was discovered by the sole purchaser of the product.

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. (more…)

For Immediate Release

February 23, 2016

Contact

Consumers

Customer Service
800-729-3354

Media

Michelle Voss
Michelle_Voss@liparifoods.com
586-447-3500 ext. 9619

Announcement

WARREN, Mich. – Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products. The products are safe for consumption by those who do not have an allergy or severe sensitivity to almonds.

The products were distributed to retail stores throughout Indiana, Kentucky, Michigan, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia.

Products were distributed under the following brand names Angeli Foods, Harding’s Markets, Goosberries Fresh Food Market, Martha’s Vineyard, Hollywood Market, Daniels Foods, Snook’s Butcher Shoppe, Martin’s, Holiday Market, The Purple Onion, Remke Market or as generic product without branding.

The affected products can be identified by:

Product Lipari Product # Lot # Weight Best By Date UPC
Dark Chocolate Covered Coffee Beans (Angeli Foods, Harding’s Markets, Goosberries Fresh Food Market, Martha’s Vineyard, Hollywood Market, Daniels Foods, Snook’s Butcher Shoppe, Martin’s, Holiday Market, The Purple Onion, Remke Market) 510526 22201512 12oz Tubs 12/21/16 094776131761
Dark Chocolate Covered Coffee Beans (Generic) 477308 22201512 12oz Tubs 12/21/16 094776131761

There are no reported illnesses in connection with these products to date. (more…)

Rucker’s Wholesale & Service Co. Issues Allergy Alert on Undeclared Peanut Ingredient in Uncle Bucks & Cabela’s Classic Candies Maple Nut Candy Peg Bags

For Immediate Release

February 23, 2016

Contact

Consumers

Rucker’s Wholesale and Service Co.
 618-945-2411 or 800-663-1857

Announcement

Rucker’s Wholesale and Service Co. of Bridgeport, IL is voluntarily recalling all of Uncle Bucks and Cabela’s Classic Candies Maple Nut candy peg bag, due to the presence of an undeclared peanut ingredient. People who have an allergy to peanuts run the risk of serious or life threatening allergic reaction if they consume this product.

The recalled Maple Nut candy was distributed nationwide in Bass Pro Shops and Cabela’s stores.

The affected product is packaged in a 2.7oz, clear bag with paper header card, both brands are UPC 7 52545 07101 3. This includes all best by codes 010116 through 020117.

One allergic reaction to date has been reported in connection with this problem. (more…)

For Immediate Release

February 23, 2016

Contact

Consumers

Marathon Ventures, Inc.
402-934-8223

Announcement

BELLEVUE, NEBRASKA – Marathon Ventures, Inc. announced today that it is voluntarily recalling various retail and bulk packages containing raw macadamia nuts as a precautionary measure because the product may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, nausea, vomiting, diarrhea (which may be bloody), and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled products were sold between July 2, 2015 and February 3, 2016, through grocery, foodservice, other retail outlets, and direct mail orders via company website nationwide. Affected products are packaged as follows:

UPC BRAND PRODUCT DESCRIPTION UNIT WT CODE DATE / LOT NUMBER LOT CODE LOCATION
0 15400 86635 4 Shurfine Macadamia Diced Nuts 5oz / 142g Best By:
2 SEP 2016
Front of bag – top right
0 15400 16635 5 Western Family Macadamia Diced Nuts 5oz / 142g Best By:
3 AUG 2016
Front of bag – top right
Best By:
4 AUG 2016
Front of bag – top right
Best By:
2 SEP 2016
Front of bag – top right
0 75450 13287 8 HyVee Macadamia Nuts 2oz / 57g Best By:
10 JUL 2016
Back of bag – mid right
0 85239 52108 3 Market Pantry Chopped Macadamia Nuts 2.25oz / 64g Best By:
13 AUG 2016
Back of bag – right side
Best By:
11 SEP 2016
Back of bag – right side
0 75049 42186 4 Pear’s Gourmet Macadamia Nuts Raw 16oz / 454g Best By:
11 SEP 2016
Front of bag – near top
Best By:
25 SEP 2016
Front of bag – near top
06509 Cash-Wa Distributing Macadamia Nuts Raw 5lbs / 2.27kg 15204 Bot right on case label
15260 Bot right on case label
Bulk Case Nutpro C.C. Macadamia Nuts Style #5 25lbs 79818 Case label

The issue was brought to the Company’s attention by the U.S. Food and Drug Administration (FDA) following a Salmonella positive product found during routine product sampling.

There have been no illnesses or injuries reported to-date affiliated with these products. Anyone concerned about an injury/illness should contact a physician immediately. Marathon Ventures, Inc. has informed the FDA of its actions and is cooperating fully with the ongoing investigation. (more…)

Recall Summary

Name of product: Smartstove freestanding pellet stoves

Hazard:

Smoke can build up inside the firebox due to ash accumulation and the glass in the door can break, posing a laceration hazard.

Consumer Contact: England’s Stove Works at 800-641-3066 from 8 a.m. to 5 p.m. ET Monday through Friday. Extended hours will be in effect until March 15, 2016 from 8 a.m. to 9 p.m. ET Monday through Friday and from 8 a.m. to 2 p.m. on Saturdays. Or, online at www.heatredefined.com and click on Notice located at the top of the page for more information and to register to receive a repair kit.

Report an Incident Involving this Product

Recall Details

Units

About 2,300

Description

This recall involves Smartstove free standing pellet stoves, with model number 55-SHSSP01 and serial numbers ranging from 101 through 2513. The cast iron pellet stove is about 36 inches high, 24 ½ inches wide, 24 inches deep and has a black satin finish. It has an arched glass door on the front with vents above the door. The Smartstove logo appears on the stove’s control panel. The model and serial numbers are located on a black plate on the top right hand corner on the back of the stove.

Incidents/Injuries

The firm has received four reports of incidents, including one report of a minor injury. (more…)

For Immediate Release

February 22, 2016

Contact

Consumers

Abdul Paracha
 1-732-650-1300 Ext 222

Announcement

Best Foods Inc. 30 Saw Mill Pond Rd,. Edison, NJ is recalling its 7 ounce packages and 14 oz. packages of Deer brand Cumin Powder because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled packages of Deer brand Cumin Powder were distributed in NY, CT, NJ, MA, PA, DE and VA and have reached consumers through retail stores.

The product comes in a clear and yellow plastic package, with no expiration dates and lots number. 7 ounce packages are marked with UPC number 714760027497and the 14 ounce packages are marked with UPC number 714760027503.

No illnesses have been reported to date in connection with this problem. (more…)