This week saw a recall on HVAD(TM) System Controllers and DC Adapters; recalls on herbal tea; recalls on handheld massagers; recalls on gas-fired furnaces; recalls on catheters; recalls on imported frozen raw tuna or ahi cubes; recalls on quiche products, recalls on frozen meals; recalls on veal, and ground veal, beef and pork products; recalls on stroller and car seat combos; recalls on cashew butter; recalls on Segway chargers; and recalls on women’s scarves.
Details are below, courtesy of cpsc.gov and recalls.gov.
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Product Recalls for the Week of May 1, 2017:
- HVAD(TM) System Controllers and DC Adapters: Medtronic announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall. Medtronic began notifying clinicians outside of the United States in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017. In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors. With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographies, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides. Patients with questions about this announcement should contact their physicians or ventricular assist device (VAD) coordinator at their hospital center. Adverse reactions or quality problems experienced with the use of this device may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Recall Date: 4/18/17
- Herbal Tea: U.S. Deer Antler Ex. & Imp. 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. 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. People experiencing these symptoms who have recently consumed these Herbal Teas should seek immediate medical attention. Consumers in possession of these products are to stop consumption and return unconsumed product to their original place of purchase. Recall Date: 5/1/17
- HoMedics Handheld Massagers: HoMedics USA LLC is recalling is handheld massagers because the cord can break near the base of the massager and expose the wires, posing an electric shock and burn hazards. This recall involves three models of handheld massagers, HHP-375H, HHP-250 and the PA-MH-THP. All models of the massagers have a 120 VAC, 60 HZ power cord. “HoMedics” is printed on the massagers. The HHP-375H model Handheld Dual Node Percussion Massager with Heat is white with a gray handle or black with a gray handle. The massager has three sets of interchangeable nodes. The HHP-250 model Handheld Hot and Cold Massager is white with a gray stripe or gray with a blue stripe. The massager has three, five or eight interchangeable nodes. The PA-MH-THP model Handheld Compact Percussion Massager with Heat is white on the bottom of the base with gray on top. The massager has two sets of interchangeable nodes. All manufacturing dates for all three models are included in the recall and the item date code can be found in either one of the cord prongs or in the rating label located on the underside of the product. Date codes can be identified as a 4-digit number WWYY where WW is the sequential week of the year and YY is the last two digits of the manufacturing year. HoMedics has received 140 reports of exposed wires, sparks, smoking and some shooting flames coming from the massagers. There have been 15 reports of burn injuries to consumer’s fingers and other parts of the body. Recalled massagers were sold at Bed Bath & Beyond, Macy’s, Rite-Aid, Walmart and other stores nationwide and HSN from August 2013 through February 2017. Consumers should immediately stop using the recalled massagers and contact HoMedics for instructions on removing the cord and to receive a refund in the form of a credit for any replacement product from the firm. Recall Date: 5/2/17
- Goodman Gas-Fired Furnaces: Goodman Manufacturing Company L.P. is recalled its gas-fired furnaces because the blower motor is not grounded, posing an electrical shock hazard to individuals servicing the units. This recall involves 80% efficiency gas-fired furnaces sold under the Goodman, Amana and Daikin brand names used with home heating and cooling systems. The recalled products have model numbers beginning AMEH80, DM80HE, and GME8, and serial numbers beginning 1609, 1610, 1611 and 1612. The brand name is shown on the outside of the furnace, and the serial number is located on the label found by opening the furnace door. Recalled furnaces were sold at Goodman, Amana and Daikin heating and cooling equipment dealers nationwide from September 2016 through January 2017. Consumers should immediately contact Goodman for a free repair. Recall Date: 5/2/17
- Wingman35 Crossing Catheters: 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. Recall Date: 5/3/17
- Imported Frozen Raw Tuna (Ahi) Cubes: The Hawaii State Department of Health (DOH) has been notified of imported frozen raw tuna or ahi cubes distributed by Tropic Fish Hawaii, LLC on Oahu that tested positive for hepatitis A. The product, imported from Indonesia, was used to prepare poke sold between April 27 – May 1 by food establishments on Oahu. The imported frozen fish was used to prepare poke sold at Times Supermarket and Shima’s locations in Aiea, Kailua, Kaneohe, Kunia, Liliha, Mililani, Waipahu, and Waimanalo. The product was also used to prepare food served or sold by GP Hawaiian Food Catering, the Crab Shack Kapolei (also known as Maile Sunset Bar & Grill in Kapolei), Aloha Sushi at 3131 N. Nimitz, and the ABC store at 205 Lewers St. Customers who purchased and consumed the product and are not vaccinated for hepatitis A are advised to consult with their doctor about vaccination. Persons who consumed poke from the affected food establishments between April 28 and May 1 may have been exposed to hepatitis A and are advised to contact their healthcare provider about receiving hepatitis A vaccine or immune globulin (IG), which may provide some protection against the disease if administered within two weeks after exposure; monitor their health for symptoms of hepatitis A infection up to 50 days after exposure; wash hands with soap and warm water frequently and thoroughly, especially after using the bathroom and before preparing food; and stay at home and contact their healthcare provider immediately if symptoms of hepatitis A infection develop. Symptoms of hepatitis A infection usually appear 2–6 weeks after exposure and include fever, fatigue, loss of appetite, abdominal discomfort, dark urine, diarrhea, and yellow skin and eyes. Individuals, including food service employees, exhibiting symptoms of hepatitis A should stay home and contact their healthcare provider. While vaccination provides the best protection, frequent handwashing with soap and water after using the bathroom, changing a diaper, and before preparing food can help prevent the spread of hepatitis A. Appropriately cooking foods can also help to prevent infection. Recall Date: 5/3/17
- Frozen Quiche Products: Maple Leaf Foods, Inc. is recalling approximately 24,768 pounds of Ready-to-Eat (RTE) fully-cooked quiche products that were not presented for re-inspection upon entry to the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. Without the benefit of full inspection, a possibility of adverse health consequences exists. The products subject to recall were produced and packaged on Feb. 8, 2017. Those products include 24-ounce individually-packaged plastic clam-shell containers of frozen “SCHNEIDERS LORRAINE HAM & CHEESE Quiche” with package code “62000 8096 9” on the individual retail containers and 24-ounce individually-packaged plastic clam-shell containers of frozen “H.E.B. Chef Prepared Foods Ham & Cheese Quiche” with package code “41220 63400 9” on the individual retail containers. The products subject to recall do not bear the USDA federal mark of inspection, but bear establishment number “Canada 277.” The products were shipped to distribution centers in Indiana and Oklahoma for further distribution to retail stores nationwide. 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. Recall Date: 5/3/17
- Beef Chile Colorado Frozen Meals: Blount Fine Foods, Corp. is recalling approximately 8,685 pounds of Beef Chile Colorado frozen meals due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. The products are mislabeled as Beef Chile Colorado, but the packaged product contains cheese enchiladas with milk as an ingredient. Milk is a known allergen and is not declared on the product label. The frozen Beef Chile Colorado products were produced on Nov. 23, 2016. Products subject to recall include 10-ounce retail cartons containing “SAFFRON ROAD BEEF CHILE COLORADO WITH MESQUITE BLACK BEANS & GARLIC RICE” with “Best By” dates of “05/23/18 AP.” The products subject to recall do not bear an establishment number on the packaging because the company was producing a U.S. Food and Drug Administration product. These items were shipped to distribution centers located in Pennsylvania and Texas. 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. Recall Date: 5/3/17
- Veal, Beef and Pork Products: Marcho Farms, Inc. is recalling approximately 5,620 pounds of boneless veal, and ground veal, beef and pork products that may be adulterated withnon-O157 Shiga toxin-producing E. coli (STEC) O111, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. The veal, beef and pork products were produced on April 11 and April 14, 2017. Products subject to recall include 60-pound cases of “VEAL BONELESS TRIMMINGS HALAL” with case code “5398” and “MANFU. DATE” of “04/11/2017;” 60-pound cases of “VEAL TRIMMINGS USDA CHOICE” with case code “98” and “MANFU. DATE” of “04/11/17;” 9-pound cases of “VEAL, BEEF, PORK GROUND FOR MEATLOAF” with case code “3122” and “Sell By” date “05/05/17;” and 10-pound cases of “VEAL, BEEF, PORK GROUND FOR MEATLOAF BULK PACK” with case code “3125.” These items were distributed to retail stores and food service locations in Illinois, New York, North Carolina, Pennsylvania, South Carolina and Virginia. The problem was discovered when the Illinois State Meat Inspection Service notified FSIS on May 2, 2017, about positive non-O157 Shiga toxin-producing E. coli (STEC) samples made with source material produced by Marcho Farms, Inc. There have been no confirmed reports of adverse reactions due to consumption of these products. 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. Recall Date: 5/4/17
- Combi Shuttle Travel Systems: Combi USA is recalling its Combi Shuttle Travel System (stroller and car seat combos) because the car seat can disengage from the stroller’s frame, posing a fall hazard to infants. This recall involves Combi Shuttle model strollers and car seats, which when used together are called a travel system. The strollers and car seats have model number 6100027 or 6100100 printed on a label on the base of the car seat and stroller’s leg. The car seat and stroller were sold in titanium (silver) and red chili (red) colors. Combi is printed on the front of the stroller and the car seat. Shuttle is printed above the model number. Recalled units were sold online at Amazon.com, Babies R Us.com, Target.com and other online retailers from June 2015 through September 2016. Recall Date: 5/4/17
- Nutty Infusions Cashew and Ginger Wasabi Cashew Butters: NOW Health Group, Inc. (NOW) is voluntarily recalling its Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter – Product Code E0541, Lot# 2124118 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. A limited quantity of Nutty Infusions was distributed online and in retail stores nationwide. Recalled products include Ellyndale® Nutty Infusions™ Roasted Cashew Butter, 10 oz. plastic jars, Item No. E0540, Lot No. 2125155, Best By Date 2/19 and Ellyndale® Nutty Infusions™ Ginger Wasabi Cashew Flavor, 10 oz. plastic jars, Item No. E0541, Lot No. 2124118, Best By Date 3/19. NOW has provided information on this voluntary recall to all its retailers who purchased this product and has encouraged retailers to make every effort to contact their customers to facilitate the return of affected products. Consumers who have purchased the recalled Nutty Infusions should stop using the product immediately and return it to place of purchase for a full refund. Recall Date: 5/4/17
- Segway Personal Transporter Off-Board Chargers: Segway, Inc. is recalling Off-Board Chargers for Segway Personal Transporters (PT) because a wire inside the charger can detach and touch the side of the charger, posing a shock hazard. This recall involves Segway PT Off-Board Chargers manufactured from January 2015 to October 2016 with part number 23288-00001. The chargers are black, box-shaped and measure 8 inches wide by 13.75 inches deep by 4 inches high. Two wires used to connect the unit to Segway PT batteries extend from one end. The Segway brand name is on the charger above these wires. Chargers with the following serial numbers are included in the recall: 15201C000362, 15201C000364, 15201C000366, 15208C000404, 15208C000406, 15222C000460, 15225C000486, 15225C000489, 15225C000494, 15242C000546, 16210C000621, 16210C000629, 16210C000630, 16210C000631, 16210C000632, 16210C000635, 16210C000636, 16214C000638, 16214C000639, 16214C000641, 16214C000642, 16214C000643, 16214C000645 and 16214C000646. The serial number and part number are on a silver data plate attached to the bottom of the charger. Recalled chargers were sold exclusively at Authorized Segway dealers and distributors and directly from Segway Inc. from January 2015 through April 2017. Consumers should immediately stop using the recalled chargers, unplug and contact Segway or the Segway dealer from whom it was purchased to receive a free replacement power cord equipped with a ground fault circuit interrupter (GFCI). Segway is contacting consumers directly. Recall Date: 5/5/17
- Women’s Scarves: DGFA Inc. is recalling women’s scarves because the scarves fail to meet federal flammability standard for clothing textiles, posing a risk of burn injuries to consumers. This recall includes DG Fashion women’s scarves with fringe. The recalled scarves measure about 78 inches long by 27 inches wide, are shimmery in appearance, and were sold in the following colors: black gold, blue, green, purple, gold and wine red. The scarves are made from 70% silk and 30% polyester. Recalled products were sold exclusively online at www.amazon.com from June 2015 through March 2017. Consumers should immediately stop using the recalled scarves and contact the firm for a full refund. DGFA and Amazon are contacting consumers who purchased the scarves directly.
