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.”

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.

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