Morrilton Packing Co. Recalls Pork Products Due to Misbranding and Undeclared Allergens
Class II Recall146-2015
Dec 9, 2015
Congressional and Public Affairs
Benjamin Bell
(202) 720-9113
WASHINGTON, Dec. 9, 2015 – Morrilton Packing Co., a Morrilton, Ark. establishment, is recalling approximately 12,146 pounds of boneless ham products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which was not declared on the product label.
The boneless hickory smoked honey ham was produced on Oct. 1, and Oct. 4, 2015. The following products are subject to recall:
8-9-lb. Plastic wrapped packages containing a single boneless ham with the label “Cedar Falls Brand Boneless Hickory Smoked Honey Cured Ham” containing a code date I14, I22, or I15.
The products subject to recall bear establishment number “EST. 10646” inside the USDA mark of inspection, and were shipped to a single distributor in Arkansas.
The problem was discovered by plant management during a review of labels.
There have been no confirmed reports of adverse reactions due to consumption of these products. 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.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Sonya Chadek, Customer Relations Manager, at (501) 354-2474. Media with questions about the recall can contact Wayne Cox, Media Affairs Manager, at (501) 269-0077.
Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at:http://www.fsis.usda.gov/reportproblem.
USDA Recall ClassificationsClass IThis is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.Class IIThis is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.Class IIIThis is a situation where the use of the product will not cause adverse health consequences.
Wednesday, December 9, 2015
Tuesday, December 8, 2015
New #foodsafety #recall undeclared Walnut Allergen in chocolate brownies
Kroger Recalls Bakery Fresh Goodness Chocolate Brownies Due to Undeclared Allergens
Consumers Kroger: 1-800-KROGERS
The Kroger Co. (NYSE: KR) said today it has recalled Bakery Fresh Goodness chocolate brownies (16 oz, tub) sold in its retail stores because the product may contain walnuts not listed on the label.
People who are allergic to walnuts could have a severe reaction if they consume this product. For consumers who are not allergic to walnuts, there is no safety issue with the product. One Kroger customer has reported a possible allergic reaction in connection with this product.
All stores operating under the JayC and Smith's names, as well as Kroger stores located in Georgia; South Carolina; Auburn, Alabama; Greater Cincinnati (including Northern Kentucky and Dayton, Ohio plus South Eastern Indiana); Central and Northwest Ohio; Northwestern West Virginia panhandle; Michigan; Hopkinsville and Bowling Green, Kentucky; Nashville and Knoxville, Tennessee; Huntsville, Alabama; Indiana (except SE Indiana and Evansville); Illinois; Eastern Missouri; Texas and Louisiana; no other Kroger locations are included.
Kroger has removed this item from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled Class 1 products through register receipt tape messages and phone calls.
Kroger is recalling the following item:
ProductUPCCodesSizeBakery Fresh Goodness Brownies11110-09172Lot numbers beginning with 15307
Purchased between Nov. 7, 2015 - Nov. 16, 201516 oz
Customers allergic to walnuts who have purchased the above product should not consume it and should return them to a store for a full refund or replacement.
Customers who have questions may contact Kroger at 1-800-KROGERS.
Kroger, one of the world's largest retailers, employs more than 400,000 associates who serve customers in 2,620 supermarkets and multi-department stores in 34 states and the District of Columbia under two dozen local banner names including Kroger, City Market, Dillons, Food 4 Less, Fred Meyer, Fry's, Harris Teeter, Jay C, King Soopers, QFC, Ralphs and Smith's. The company also operates 780 convenience stores, 327 fine jewelry stores, 1,342 supermarket fuel centers and 37 food processing plants in the U.S. Recognized by Forbes as the most generous company in America, Kroger supports hunger relief, breast cancer awareness, the military and their families, and more than 30,000 schools and community organizations. Kroger contributes food and funds equal to 200 million meals a year through more than 100 Feeding America food bank partners. A leader in supplier diversity, Kroger is a proud member of theBillion Dollar Roundtable and the U.S. Hispanic Chamber's Million Dollar Club.
Consumers Kroger: 1-800-KROGERS
The Kroger Co. (NYSE: KR) said today it has recalled Bakery Fresh Goodness chocolate brownies (16 oz, tub) sold in its retail stores because the product may contain walnuts not listed on the label.
People who are allergic to walnuts could have a severe reaction if they consume this product. For consumers who are not allergic to walnuts, there is no safety issue with the product. One Kroger customer has reported a possible allergic reaction in connection with this product.
All stores operating under the JayC and Smith's names, as well as Kroger stores located in Georgia; South Carolina; Auburn, Alabama; Greater Cincinnati (including Northern Kentucky and Dayton, Ohio plus South Eastern Indiana); Central and Northwest Ohio; Northwestern West Virginia panhandle; Michigan; Hopkinsville and Bowling Green, Kentucky; Nashville and Knoxville, Tennessee; Huntsville, Alabama; Indiana (except SE Indiana and Evansville); Illinois; Eastern Missouri; Texas and Louisiana; no other Kroger locations are included.
Kroger has removed this item from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled Class 1 products through register receipt tape messages and phone calls.
Kroger is recalling the following item:
ProductUPCCodesSizeBakery Fresh Goodness Brownies11110-09172Lot numbers beginning with 15307
Purchased between Nov. 7, 2015 - Nov. 16, 201516 oz
Customers allergic to walnuts who have purchased the above product should not consume it and should return them to a store for a full refund or replacement.
Customers who have questions may contact Kroger at 1-800-KROGERS.
Kroger, one of the world's largest retailers, employs more than 400,000 associates who serve customers in 2,620 supermarkets and multi-department stores in 34 states and the District of Columbia under two dozen local banner names including Kroger, City Market, Dillons, Food 4 Less, Fred Meyer, Fry's, Harris Teeter, Jay C, King Soopers, QFC, Ralphs and Smith's. The company also operates 780 convenience stores, 327 fine jewelry stores, 1,342 supermarket fuel centers and 37 food processing plants in the U.S. Recognized by Forbes as the most generous company in America, Kroger supports hunger relief, breast cancer awareness, the military and their families, and more than 30,000 schools and community organizations. Kroger contributes food and funds equal to 200 million meals a year through more than 100 Feeding America food bank partners. A leader in supplier diversity, Kroger is a proud member of theBillion Dollar Roundtable and the U.S. Hispanic Chamber's Million Dollar Club.
Friday, December 4, 2015
Updated #foodsafety #investigation of #ecoli outbreak at Chipotle Mexican Grill
FDA Investigates Multistate Outbreak of E. coli O26 Infections Linked to Chipotle Mexican Grill Restaurants
What is the Problem and What is Being Done About It?What are the Symptoms of E. coli O26?Who is at Risk?What Do Consumers Need To Do?Who Should be Contacted?Additional Information
The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of E. coli infections.
Update: December 4, 2015
Three additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update, Illinois, Maryland, and Pennsylvania.Fifty-two people infected with the outbreak strain of STEC O26 have now been reported from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.The investigation is still ongoing to determine what specific food is linked to illness.
What is the Problem and What is Being Done About It?
The FDA and the Centers for Disease Control and Prevention (CDC) along with state and local officials are investigating an outbreak ofE. coli O26 infections that have been linked to food served at Chipotle Mexican Grill restaurants in several states.
As of December 4, 2015, the CDC reports a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27). There have been 20 reported hospitalizations. There have been no reports of hemolytic uremic syndrome (HUS) and no deaths. Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began.
Investigators are also using whole genome sequencing, an advanced laboratory technique, to get more information about the DNA fingerprint of the STEC O26 bacteria causing illness. To date, whole genome sequencing has been performed on STEC O26 isolates from 21 ill people from California (2), Minnesota (2), New York (1), and Washington (16). All 21 isolates were highly related genetically to one another. This provides additional evidence that illnesses outside the Pacific Northwest, could be related to the illnesses in Washington .
Chipotle Mexican Grill has reopened all of its restaurants in Washington and Oregon that had been closed in response to the investigation. Chipotle Mexican Grill worked in close consultation and collaboration with health officials throughout the investigation to determine whether it was appropriate to reopen these restaurants. Chipotle reports taking the following actions, among others, prior to opening:
Confirming that all microbial testing performed by the company did not yield E. coli (more than 2,500 tests of Chipotle's food, restaurant surfaces, and equipment all showed no E. coli)Confirming that no employees in these restaurants were sickened from this incidentExpanded testing of fresh produce, raw meat, and dairy items prior to restocking restaurantsImplementing additional safety procedures, and audits, in all of its 2,000 restaurants to ensure that robust food safety standards are in placeWorking closely with federal, state, and local government agencies to ensure that robust food safety standards are in placeReplacing all ingredients in the closed restaurantsConducted additional deep cleaning and sanitization in all of its closed restaurants (will conduct deep cleaning and sanitization additionally in all restaurants nationwide)
The FDA continues to work with Chipotle Mexican Grill restaurants as well as federal, state and local agencies to gather information about the supply chain(s). The FDA will continue to provide updates on the investigation as they become available.
What is the Problem and What is Being Done About It?What are the Symptoms of E. coli O26?Who is at Risk?What Do Consumers Need To Do?Who Should be Contacted?Additional Information
The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of E. coli infections.
Update: December 4, 2015
Three additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update, Illinois, Maryland, and Pennsylvania.Fifty-two people infected with the outbreak strain of STEC O26 have now been reported from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.The investigation is still ongoing to determine what specific food is linked to illness.
What is the Problem and What is Being Done About It?
The FDA and the Centers for Disease Control and Prevention (CDC) along with state and local officials are investigating an outbreak ofE. coli O26 infections that have been linked to food served at Chipotle Mexican Grill restaurants in several states.
As of December 4, 2015, the CDC reports a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27). There have been 20 reported hospitalizations. There have been no reports of hemolytic uremic syndrome (HUS) and no deaths. Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began.
Investigators are also using whole genome sequencing, an advanced laboratory technique, to get more information about the DNA fingerprint of the STEC O26 bacteria causing illness. To date, whole genome sequencing has been performed on STEC O26 isolates from 21 ill people from California (2), Minnesota (2), New York (1), and Washington (16). All 21 isolates were highly related genetically to one another. This provides additional evidence that illnesses outside the Pacific Northwest, could be related to the illnesses in Washington .
Chipotle Mexican Grill has reopened all of its restaurants in Washington and Oregon that had been closed in response to the investigation. Chipotle Mexican Grill worked in close consultation and collaboration with health officials throughout the investigation to determine whether it was appropriate to reopen these restaurants. Chipotle reports taking the following actions, among others, prior to opening:
Confirming that all microbial testing performed by the company did not yield E. coli (more than 2,500 tests of Chipotle's food, restaurant surfaces, and equipment all showed no E. coli)Confirming that no employees in these restaurants were sickened from this incidentExpanded testing of fresh produce, raw meat, and dairy items prior to restocking restaurantsImplementing additional safety procedures, and audits, in all of its 2,000 restaurants to ensure that robust food safety standards are in placeWorking closely with federal, state, and local government agencies to ensure that robust food safety standards are in placeReplacing all ingredients in the closed restaurantsConducted additional deep cleaning and sanitization in all of its closed restaurants (will conduct deep cleaning and sanitization additionally in all restaurants nationwide)
The FDA continues to work with Chipotle Mexican Grill restaurants as well as federal, state and local agencies to gather information about the supply chain(s). The FDA will continue to provide updates on the investigation as they become available.
Thursday, December 3, 2015
New #foodsafety #recall of pureed meat products due to #misbranding & #undeclared #allergen
K. Heeps Recalls Pureed Meat Products Due to Misbranding and Undeclared Allergens
Class I Recall 145-2015
Health Risk: High Dec 3, 2015
Congressional and Public Affairs
Richard J. McIntire
(202) 720-9113
WASHINGTON, Dec. 3, 2015 – K. Heeps, Inc., an Allentown, Pa. establishment, is recalling approximately 152,010 pounds of roast beef products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products may contain milk and wheat, known allergens which are not declared on the product label.
The frozen, pureed roast beef items were produced on various dates between Dec. 18, 2014, and Nov. 20, 2015. The following products are subject to recall:
4.5-lb. boxes containing 24, 3-ounce trays of “CafePuree MEAT VARIETY PACK”
4.5-lb. boxes containing 24, 3-ounce trays of “CafePuree SAVORY ROAST BEEF”
4.5-lb. boxes containing 24, 3-ounce trays of “SYSCO IMPERIAL MEAT VARIETY PACK”
4.5-lb. boxes containing 24, 3-ounce trays of “SYSCO SAVORY ROAST BEEF.”
The products subject to recall bear establishment number “EST. 9379” or “EST. 9379A” inside the USDA mark of inspection. These items were shipped to distributors in Pennsylvania and exported to Canada for institutional use.
The problem was discovered by FSIS personnel during in-plant verification activities. A vegetable flavoring used in the products may contain the allergens.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an allergic reaction, 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.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers and media with questions about the recall can contact Beau Heeps, company president, at (610) 530-8010.
Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854 FREE) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: http://www.fsis.usda.gov/reportproblem.
Wednesday, December 2, 2015
New #foodsafety #recall possible #salmonella contamination of JEM Nut Butter Spread
JEM Raw Chocolate LLC Voluntarily Recalls Nut Butter Spread Products Due To Possible Health Risk
Consumers: JEM Raw Chocolate, LLC
(541) 728-3844
JEM Raw Chocolate, LLC (JEM Raw) of Bend, Oregon announced a voluntary recall of its full line of all nut butter spreads within expiry because it has the potential to 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, diarrhea (which may be bloody), nausea, vomiting 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.
Health authorities, including the Food and Drug Administration (FDA), Oregon Health Authority (OHA), Oregon Department of Agriculture (ODA), Center for Disease Control (CDC) have linked the illnesses to person(s) who have consumed nut spreads, including JEM Raw products. There have been eleven (11) illnesses reported but no deaths or hospitalizations to date.
In light of this investigation, and with an abundance of caution, JEM Raw has initiated a voluntary recall of all products and sizes, packaged in glass jars, and sold under brand name JEM Raw Organics.
The following products are recalled:
Product NameNet Weight (oz.)UPCCashew Cardamom - Sprouted Cashew Almond Spread16 09728 97861 7Cinnamon Red Maca - Sprouted Almond Spread16 09728 97862 4Hazelnut Raw Cacao - Sprouted Hazelnut Spread16 09728 97865 5Superberry Maqui Camu - Sprouted Almond Spread16 09728 97864 8Cashew Cardamom - Sprouted Cashew Almond Spread66 09728 97860 0Cinnamon Red Maca - Sprouted Almond Spread66 09728 97848 8Hazelnut Raw Cacao -Sprouted Hazelnut Spread66 09728 97857 0Superberry Maqui Camu - Sprouted Almond Spread66 09728 97858 7Cashew Cardamom - Sprouted Cashew Almond Spread166 09728 97854 9Cinnamon Red Maca - Sprouted Almond Spread166 09728 97850 1Hazelnut Raw Cacao - Sprouted Hazelnut Spread166 09728 97851 8Superberry Maqui Camu - Sprouted Almond Spread166 09728 97852 5
The JEM Raw recalled products were distributed nationwide in retail stores and through mail order. Products are distributed between June 2015 and November 2015.
JEM Raw is working with distributors and retailers to remove these products from retail shelves. Consumers do not need to return the product to the store where it was purchased. Instead, consumers should discard any product and its container. JEM Raw will work directly with each consumer to manage replacement of its product.
Additional details can be found atwww.jemraw.com. Those with questions may contact JEM Raw Chocolate, LLC at (541) 728-3844 between 9am 4pm PST, Monday through Friday.
Jen Moore, co-founder and CEO, said, “We are taking these steps because consumer safety is our top priority. As a health food company, our customer’s health is our number one priority. Although no JEM Raw products have tested positive for Salmonella, we feel strongly that issuing a voluntary recall is the right thing to do. JEM is working closely with the FDA, ODA, and OHA to determine the root cause of the outbreak.”
Consumers: JEM Raw Chocolate, LLC
(541) 728-3844
JEM Raw Chocolate, LLC (JEM Raw) of Bend, Oregon announced a voluntary recall of its full line of all nut butter spreads within expiry because it has the potential to 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, diarrhea (which may be bloody), nausea, vomiting 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.
Health authorities, including the Food and Drug Administration (FDA), Oregon Health Authority (OHA), Oregon Department of Agriculture (ODA), Center for Disease Control (CDC) have linked the illnesses to person(s) who have consumed nut spreads, including JEM Raw products. There have been eleven (11) illnesses reported but no deaths or hospitalizations to date.
In light of this investigation, and with an abundance of caution, JEM Raw has initiated a voluntary recall of all products and sizes, packaged in glass jars, and sold under brand name JEM Raw Organics.
The following products are recalled:
Product NameNet Weight (oz.)UPCCashew Cardamom - Sprouted Cashew Almond Spread16 09728 97861 7Cinnamon Red Maca - Sprouted Almond Spread16 09728 97862 4Hazelnut Raw Cacao - Sprouted Hazelnut Spread16 09728 97865 5Superberry Maqui Camu - Sprouted Almond Spread16 09728 97864 8Cashew Cardamom - Sprouted Cashew Almond Spread66 09728 97860 0Cinnamon Red Maca - Sprouted Almond Spread66 09728 97848 8Hazelnut Raw Cacao -Sprouted Hazelnut Spread66 09728 97857 0Superberry Maqui Camu - Sprouted Almond Spread66 09728 97858 7Cashew Cardamom - Sprouted Cashew Almond Spread166 09728 97854 9Cinnamon Red Maca - Sprouted Almond Spread166 09728 97850 1Hazelnut Raw Cacao - Sprouted Hazelnut Spread166 09728 97851 8Superberry Maqui Camu - Sprouted Almond Spread166 09728 97852 5
The JEM Raw recalled products were distributed nationwide in retail stores and through mail order. Products are distributed between June 2015 and November 2015.
JEM Raw is working with distributors and retailers to remove these products from retail shelves. Consumers do not need to return the product to the store where it was purchased. Instead, consumers should discard any product and its container. JEM Raw will work directly with each consumer to manage replacement of its product.
Additional details can be found atwww.jemraw.com. Those with questions may contact JEM Raw Chocolate, LLC at (541) 728-3844 between 9am 4pm PST, Monday through Friday.
Jen Moore, co-founder and CEO, said, “We are taking these steps because consumer safety is our top priority. As a health food company, our customer’s health is our number one priority. Although no JEM Raw products have tested positive for Salmonella, we feel strongly that issuing a voluntary recall is the right thing to do. JEM is working closely with the FDA, ODA, and OHA to determine the root cause of the outbreak.”
New #drug #recall of OmniPod insulin management system due to needle malfunction
Insulet Corporation Issues Field Safety Notification of OmniPod Insulin Management System
Consumers: Insulet Customer Care
1-855-407-3729
On November 2, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally.
Insulet has notified its distributors and customers by email, FedEx, and phone calls beginning on November 2, 2015, as well as all applicable regulatory agencies, including U.S. Food and Drug Administration (FDA). Consumers with questions may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.
This Notification is due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once this issue was recognized, the Company corrected the manufacturing process and implemented additional inspection steps.
This Notification does not affect the OmniPod Personal Diabetes Manager (PDM).
In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA). If a patient has activated a Pod and experiences unexpected elevated blood glucose levels, a healthcare professional should be consulted.
The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Consumers who have Pods from the affected lots should ensure the needle mechanism has deployed properly, and may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.
OmniPods from the affected lots listed below were distributed to customers in September 2015:
DistributionCatalog NumberDescriptionLot NumberUnited StatesPOD-ZXP420OmniPod®, Insulin Management SystemL41880
L41881
L41892
L41895
L41897
L41898
L41899
L41900
L41901
L41902
L41903
L41904
L41905
L41906
L41907International14810OmniPod®, Insulin Management SystemL41908
L41910
F41935
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 formwww.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 1-800-332-0178.
Consumers: Insulet Customer Care
1-855-407-3729
On November 2, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally.
Insulet has notified its distributors and customers by email, FedEx, and phone calls beginning on November 2, 2015, as well as all applicable regulatory agencies, including U.S. Food and Drug Administration (FDA). Consumers with questions may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.
This Notification is due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once this issue was recognized, the Company corrected the manufacturing process and implemented additional inspection steps.
This Notification does not affect the OmniPod Personal Diabetes Manager (PDM).
In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA). If a patient has activated a Pod and experiences unexpected elevated blood glucose levels, a healthcare professional should be consulted.
The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Consumers who have Pods from the affected lots should ensure the needle mechanism has deployed properly, and may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.
OmniPods from the affected lots listed below were distributed to customers in September 2015:
DistributionCatalog NumberDescriptionLot NumberUnited StatesPOD-ZXP420OmniPod®, Insulin Management SystemL41880
L41881
L41892
L41895
L41897
L41898
L41899
L41900
L41901
L41902
L41903
L41904
L41905
L41906
L41907International14810OmniPod®, Insulin Management SystemL41908
L41910
F41935
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 formwww.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 1-800-332-0178.
Tuesday, December 1, 2015
New #medical #device #recall of digital temple thermometers due to inaccurate temperature readings lower than actual.
Bestmed, LLC Issues Nationwide Recall Of Digital Temple Thermometer (DTT™), Model No. KD-2201 Manufactured By K-Jump Health Co., Ltd.
Consumers: Bestmed
DTTRecall@bestmedusa.com
(877) 299-6700
Fax: (303) 271-0163
On November 12, 2015, Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N: 3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in November 2015.
Some Digital Temple Thermometers contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures, which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate care (generally an over-the-counter fever reduction medication) or receive more care than appropriate, when relying solely on the temperature display on the thermometer.
Consumers who have a Digital Temple Thermometer should immediately stop using the device. Consumers may return the thermometer to Bestmed for a replacement thermometer.
The following model number(s) have been recalled:
KD-2201
(Note: Model KD-2201L is not subject to this recall action)
The Digital Temple Thermometer is a hand-held thermometer and can be identified by the DTT™ logo on the face, as shown below:
The back of the thermometer has a label with the KD-2201 designation as shown below. The slash-mark (/) is not part of the model number. The lot number may be found on the bottom of the back label, immediately after the designation “S/N:”. In the picture below, the lot number is S/N: 3113.
Bestmed voluntarily initiated the recall after becoming aware of the inaccurate temperature readings by the Digital Temple Thermometer, and confirming the source of the performance problem with the manufacturer, K-Jump Health Co., Ltd.
The Digital Temple Thermometer was distributed throughout the United States for direct sale and resale through consumer retail stores, and through consumer retail stores in Canada under the following packaging labels:
Bestmed
Good Neighbor
Kroger
Medline
Meijer
Premier Value
Safeway
Life Brand
Target
Top Care
Best Choice (Value Merchandise)
Western Family
To arrange for the return and replacement of the thermometer or to ask questions, consumers should contact the Bestmed via telephone at (877) 299-6700, facsimile at (303) 271-0163, or email at DTTRecall@bestmedusa.com, at any time. Our office is available Monday through Friday 9:00 AM to 7:30 PM, Eastern Time to speak with a consumer support specialist, and all messages and email will be responded to promptly.
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, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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