It can sometimes be hard to plan for the road ahead—including
your finances. But if you set your retirement saving goals early on
(and stick with them), you can take charge of your financial future.
myRA can help you save for retirement if you don't have access to an employer-sponsored plan or lack other options to save.
Learn the basics of retirement, including a tool to figure out the best age to claim your Social Security benefits, at USA.gov.
Μάι 5 τις 5:44 μ.μ.
Center for Food Safety and Applied Nutrition
Constituent Update
Interagency Food Safety Analytics Collaboration Webinar: Strategic Plan and Future Directions
May 5, 2017
The
Interagency Food Safety Analytics Collaboration (IFSAC) invites the
public to participate in a webinar on Wednesday, May 31, 2017 from 4:00
to 5:00 p.m. Eastern Time. The one-hour webinar will describe IFSAC's new strategic plan for 2017–2021, provide project updates, and offer a question-and-answer session.
The webinar is open to the public, but space is limited. IFSAC requests all participants register by Friday, May 26, 2017 at https://ifsac-2017-spring.eventbrite.com
to reserve a spot. Registered participants will receive a confirmation
email with the webinar agenda and detailed instructions for accessing
the webinar. A recording and transcript will be posted to IFSAC's events page at a later time.
IFSAC
is a federal tri-agency collaboration among USDA's Food Safety and
Inspection Service (FSIS), the Centers for Disease Control and
Prevention (CDC), and the U.S. Food and Drug Administration (FDA). The
goal of this collaboration is to improve coordination of federal food
safety analytic efforts and address cross-cutting priorities for food
safety data collection, analysis, and use. Projects and studies aim to
identify foods that are important sources of illnesses.
For more information on IFSAC, please visit the collaboration's website.
For detailed information
pertaining to this Recalls, Market Withdrawals and Safety Alerts
message, please click the link at the beginning of this bulletin.
Ventricular
Assist Device Controllers and DC Adapter by Medtronic Mechanical
Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated
Controller, Power Management Software
AUDIENCE: Cardiology, Risk Manager, Transplantation, Nursing, Patient
ISSUE:
Medtronic Mechanical Circulatory Support is expanding this recall to
include an additional product code and instructions to exchange recalled
products.
The
company recalled the HVAD controller due to a loose power connector
which may cause the rear portion of the pump’s driveline connector to
become separated from the front portion of the driveline connector. A
loose connector may allow moisture to enter the controller causing
corrosion, electrical issues, reduced speaker volume and connection
failures. If the speaker volume is decreased, the patient may not hear
the alarm. If there is a loss of connection, the pump may stop which
could cause serious adverse health consequences, including death.
Since the issuance
of the November 2016 recall, Medtronic Mechanical Circulatory Support
has developed an updated HVAD controller and power management software
to address the power connector issues.
- Serial Numbers: All HeartWare Controllers
- Product Codes: 1400, 1401, 1403, 1407, and the additional code 1435 for the HVAD DC adapter
- Manufacturing Dates: March 1, 2006 to December 1, 2016
- Distribution Dates: October 11, 2006 to December 1, 2016
BACKGROUND:
The HeartWare Ventricular Assist Device (HVAD) helps deliver blood from
the heart to the rest of the body. It is used in patients who are at
risk of death from end-stage left ventricular heart failure and who are
waiting for a heart transplant.
RECOMMENDATIONS:
- Review the notice and forms, and forward the notice to other staff within their organizations for their awareness;
- Complete, sign, and
return the “Acknowledgement Form” to Medtronic Mechanical Circulatory
Support within 30 days of receipt of the letter;
- Complete training that will cover the new product labeling including the instructions for use and patient manual;
- Quarantine and
replace affected HVAD controllers, DC adapters, instructions for use,
emergency responder guides and patient manuals in hospital inventory
after training is complete;
- Notify and schedule each of their patients as soon as possible for an appointment to exchange their controllers;
- Return all quarantined HVAD controllers and DC adapters to Medtronic Mechanical Circulatory Support; and
- Once the affected product in inventory has been identified and returned, complete and return the “Completion Form” to con2.0@medtronic.com
or the Medtronic Mechanical Circulatory Support representative no later
than 12 months from the date of the letter according to the
instructions on the form.
Healthcare
professionals and patients are encouraged to report adverse events or
side effects related to the use of these products to the FDA's MedWatch
Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form
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
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
May 4, 2017
New and Generic Drug Approvals
May 3, 2017
May 2, 2017
Μάι 5 τις 3:17 μ.μ.
| Join the conversation using hashtag #SmallBusinessWeek
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National Small Business Week Road Tour Ends in Fresno, CA
Friday, May 5
12:00 pm - 1:30 pm ET | 9:00 am- 10:30 am PT
The National Small
Business Week road tour makes its final stop in California’s largest Central
Valley city - Fresno. Agriculture is king
in California’s Central Valley, home to more than 250 unique crops and much of
the United State’s fruits, vegetables and nuts. During this event, you’ll hear from SBA Administrator Linda McMahon as
well as successful business owners such as Fred Ruiz, Founder of Ruiz Foods
and Ron Heskett, CEO of
Borga Steel.
How you can
participate:
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