The Washington State Department of Labor and Industries has now published final regulations implementing Initiative 1433 — the new statewide paid sick leave law passed by the voters in November 2016. These regulations have been much-anticipated by Washington employers, and they provide new details about how employers will be expected to comply with the statewide paid sick leave law that goes into effect on Jan. 1, 2018.

Lane Powell’s Employment Team has read the final regulations and compiled this handy list of the top 10 takeaways from the paid sick leave regulations:

1. Which employees are covered? Every non-exempt employee who works in the state of Washington is entitled to accrue paid sick leave starting on January 1, 2018. Non-exempt seasonal, temporary, on-call and part-time employees are all covered. Many employers’ current paid sick leave and/or PTO policies do not extend to these employee classifications and will need to be updated before the New Year.

2. Does that mean that exempt employees are not covered by Washington State’s paid sick leave law? Yes. Exempt employees are not covered by the state law. But exempt employees are covered by other local ordinances, including Seattle’s Paid Sick and Safe Time Ordinance, so be careful. An employer may be more generous than legally required, and provide paid sick leave to exempt employees, even if not legally required to do so. Extending paid sick leave benefits to exempt employees may also make sense from a practical standpoint.

3. How much paid sick leave do employees get? Covered non-exempt employees must accrue paid sick leave at the rate of one hour of paid sick leave for every 40 hours worked.

4. May employers place caps on the amount of paid sick leave employees can accrue or use? No caps on accrual or use are permitted. Employees must be allowed to accrue paid sick leave on all hours worked for the entire year.

5. May employers pay premium pay in lieu of providing leave? No. Although some local ordinances allow premium pay in lieu of leave, this is not permitted under the Washington paid sick leave law.

6. May employers offer employees the option to cash out their accrued, unused leave balances at year-end? Yes. Although employees must be allowed to carry-over up to 40 hours of unused paid sick leave to the next year, an employer may elect to cash out an employee’s accrued, unused paid sick leave balance which exceeds 40 hours.

7. May employers frontload paid sick leave? Yes, but the amount of paid sick leave that the employer frontloads must equal or exceed the amount the employee would receive if he or she accrued leave at the rate of one hour of leave for every 40 hours worked. Unless the employer knows with certainty the number of hours the employee will work during the year, calculating the amount of leave to frontload may be difficult. Additionally, unlike many local ordinances, frontloading leave does not exempt employers from the requirement to allow carry-over of up to 40 hours of leave to the next year.

8. What is the rate of pay for paid sick leave? For each hour of paid sick leave used, an employee must be paid the greater of: (a) minimum wage, or (b) the employee’s “normal hourly compensation,” which means the rate of pay the employee would have earned for the hours had the employee come to work. However, the “normal hourly compensation” does not include overtime, tips, gratuities, service charges, holiday pay or other premium rates, unless the employer or a collective bargaining agreement allows for such considerations. On the other hand, where an employee’s normal hourly compensation is a shift-differential, the differential rate is the “normal hourly compensation” and must be paid for paid sick leave.

9. May employers request verification for use of paid sick leave for absences less than three days? No. Verification may be requested for absences exceeding three days. For shorter absences, verification is not permitted, even in instances of perceived patterns of abuse. Washington’s paid sick leave law does, however, allow employers to request medical verification if permitted or required to do so under other federal, state or local laws or ordinances.

10. May employers withhold payment of paid sick leave if the leave was not for an authorized purpose? Yes. If an employer can demonstrate that an employee’s use of paid sick leave was for a purpose not authorized by the law, the employer may withhold payment for the use of paid sick leave. However, the employer may not subsequently deduct those hours from an employee’s accrued, unused paid sick leave bank.

Krista N. Hardwick is an attorney at Lane Powell. The firm is hosing a Paid Sick Leave webinar on Nov. 15. Contact Geneva Granatstein for more information on the webinar.

~ politics petitions pollution and pop culture

~ 2018 What you need to know about Seattle’s Sweetened Beverage Tax ~ 2018

01/05/2018 Nativegrl77

Beginning Jan. 1, 2018, the City of Seattle will impose a sweetened beverage tax (SBT) on the distribution of sweetened beverages within Seattle city limits. Key aspects to note about this new tax:

The tax is imposed and collected at the distributor level.
A foodservice operator will only be liable for paying the tax if the operator purchases sweetened beverages or syrups outside of Seattle for resale within Seattle city limits. In this case, the operator is considered a self-distributor and must pay the tax.
The tax is on sweetened beverages and concentrates such as syrups used to create sweetened beverages. The tax on concentrates is based on the finished product and is calculated using the manufacturers’ instructions. In the absence of manufacturer’s instructions, it will be presumed that one ounce of syrup yields one 12-ounce beverage.
Distributors can, with documentation, recalculate rates for syrups that are used in non-standard ways and/or exempt products based on use. Foodservice operators will need to ask their distributors for their policies and practices in addressing non-standard uses.

What is the sweetened beverage tax?

Seattle’s SBT was passed by the City Council (Ordinance 125324) and signed into law in June 2017. It is a tax on the distribution of sweetened beverage products. For sweetened beverages, the tax rate is 1.75 cents per fluid ounce. For concentrates such as syrups, the tax shall be calculated using the largest volume of beverage that would typically be produced by the amount of concentrate distributed based on the manufacturer’s instructions or industry practice.

Who pays the tax?

Distributors of sweetened beverages are responsible for paying the tax. A distributor is any person that distributes sweetened beverages for retail sale in Seattle.

If a retailer brings its own sweetened beverages into the city to sell, that retailer is deemed to be a self-distributor. In this situation, the retailer would be subject to the sweetened beverage tax. For example, a food truck operator purchases soda from a business outside of Seattle and sells the soda from the truck at locations in Seattle. The food truck operator is then a self-distributor and will need to report and pay the tax.

When does the tax take effect?

The tax takes effect on Jan. 1, 2018. Distributors responsible for the tax will report and pay on the same schedule as their business and occupation taxes (B&O).

What is the tax rate?

For sweetened beverages, the tax rate is 1.75 cents per fluid ounce. Total fluid ounces are the combined total of ready-to-consume ounces as well as the ounces calculated for concentrates. For concentrates, the tax shall be calculated using the largest volume of beverage that would typically be produced by the amount of concentrate distributed based on the manufacturer’s instructions or industry practice.

What sweeteners or syrup are subject to the tax?

Caloric sweetener means any substance or combination of substances that contains calories, is suitable for human consumption and that humans perceive as sweet. This includes, but is not limited to, sugar, sucrose, dextrose, fructose, glucose and other monosaccharides and disaccharides; corn syrup or high fructose syrup; and honey.

What beverages are included and excluded as a “sweetened beverage?”

“Sweetened beverage” includes all drinks and beverages commonly referred to as soda, pop, cola, soft drinks, sports drinks, energy drinks, sweetened ice teas and coffees, and other products with added caloric sweeteners, including but not limited to juice with added caloric sweetener, flavored water with added caloric sweetener, and non-alcoholic mix beverages that may or may not be mixed with alcohol.

Excluded beverages:

Any beverage in which natural milk is the primary ingredient. “Milk” is defined as a natural fluid milk, regardless of animal sources or butterfat content. Plant-based milk substitutes that are marketed as milk, such as but not limited to, soy milk, coconut milk, rice milk, and almond milk, are considered natural milk.
Any beverage consisting of 100 percent natural fruit or vegetable juice with no added sweetener.
Any beverage that contains fewer than 40 calories per 12-ounce serving.
Alcoholic beverages. This exclusion does not apply to bar mixers that sweeten alcoholic drinks.

Will distributors increase their prices?

It is expected that distributors will likely raise prices on sweetened beverages to offset the tax and its administrative burden.

I am a restaurant owner. Do I have any obligation under the tax?

The responsibility for paying the SBT is on the distributor, not on the restaurant. Restaurant operators who purchase sweetened beverages or syrups from a distributor will be required to identify their distributors if requested by the City.

Retailers who bring in sweetened beverages or syrups from a business outside the city limits will be responsible for the tax as they are deemed to be the distributor.

ILLUSTRATIVE EXAMPLES

EXAMPLE 1: SBT basics: How is the tax calculated and who pays?

ABC Distributor distributes 20 bottles of syrups to a restaurant in Seattle. The restaurant uses the syrups to make Italian sodas and other house beverages.

Question 1: Is SBT due on this distribution?

Answer: Yes. ABC is distributing a concentrate that will be combined with other ingredients to create a beverage for retail sale in Seattle. It is presumed that the restaurant, not the customer, will use the syrup to create sweetened beverages that are sold to its customers.

Question 2: How much SBT is due on the bottles of syrups?

Answer: The amount of SBT due is based on the total whole ounces of beverages that can be created from the syrup based on the manufacturer’s instructions or industry practice. For example, each bottle contains approximately 25 ounces (750 ml) and instructions provide for one ounce of syrup to make a 12-ounce Italian soda. Therefore, one bottle will potentially make 300 ounces of Italian sodas. This equates to $5.25 of SBT per bottle (300 oz. of sweetened beverage X 0.0175). Total SBT due for this distribution to the restaurant will be $105.00. (20 bottles x $5.25).

Question 3: Who will pay the SBT to the City of Seattle?

Answer: ABC Distributor pays the SBT because the SBT is imposed on the distributor of sweetened beverages, not on the restaurant.

EXAMPLE 2: When syrups do not have manufacturer’s instructions on usage.

ABC Distributor distributes 100 bottles of flavored syrups to restaurants in Seattle. The syrups do not contain any manufacturer’s instructions as to the amount of syrup to be used in creating a sweetened beverage.

Question: How does ABC Distributor calculate the amount of tax that is due on the distributions of syrups if there are no instructions from the manufacturer?

Answer: If there are no instructions from the manufacturer, or if the manufacturer provides for a variety of measurements for different beverages, then ABC Distributor may presume one ounce of syrup yields one 12-ounce beverage, unless the distributor has documentation to establish otherwise.

EXAMPLE 3: A restaurant group purchases syrups for use at locations both in and outside of Seattle.

MN Restaurant Chain has locations inside and outside Seattle. MN Restaurant orders its sweetened beverages from ABC Distributor which distributes the sweetened beverages to MN’s primary location in Seattle. MN then distributes the sweetened beverages to its different locations based on their needs. In this case, MN issues a Redistribution Certificate to ABC Distributor. ABC accepts the Redistribution Certificate from MN.

Question 1: Who is liable for the SBT?

Answer: MN has provided ABC Distributor a Redistribution Certificate, which places the responsibility to pay the SBT on MN. ABC Distribution may now exclude the sweetened beverages distributed to MN Restaurant Chain from the SBT. ABC Distribution will need to maintain copies of the Redistribution Certificate from MN in its records to support the excluded distributions as well as provide a copy of the distribution certificate it received from MN to the City.

Question 2: On what sweetened beverages will MN be liable for the SBT?

Answer: MN will owe SBT on the sweetened beverages that it distributed to its locations where the sweetened beverages will be offered for retail sale in Seattle. MN will not report and pay SBT on sweetened beverages distributed to its locations outside Seattle. MN will need to maintain documentation on the inventory that it distributed both inside and outside Seattle.

EXAMPLE 4: When a restaurant outside of Seattle becomes a distributor.

XYZ Pizza has locations just outside Seattle. XYZ Pizza will make deliveries into Seattle. MN also sells beverages with its pizza on request.

Question: Is XYZ liable for SBT?

Answer: Yes. In this instance, XYZ is deemed to be distributing sweetened beverages in Seattle. XYZ is liable for SBT on sweetened beverages that it distributes for retail sale in Seattle.

EXAMPLE 5: What happens when a Seattle restaurant purchases syrups or sweetened beverages outside of the city?

JM operates a food truck that sells food and sweetened beverages (e.g. soda) in Seattle. JM purchases its supplies including sweetened beverages from a supplier located outside Seattle.

Question 1: Is JM liable for SBT?

Answer: Yes. JM is distributing sweetened beverages into Seattle because it is bringing into Seattle and ultimately offering the sweetened beverages for retail sale inside Seattle. JM is liable for SBT on the sweetened beverages it distributes in Seattle for sale at retail.

Question 2: What if JM purchases its sweetened beverages from a supplier located in Seattle?

Answer: If JM purchases sweetened beverages from a supplier located in Seattle then JM will not be liable for SBT on those sweetened beverages it sells in Seattle that it also purchased from a supplier located in Seattle. In this instance, it is presumed that the SBT was already paid on the beverages previously distributed to the supplier located in Seattle.

EXAMPLE 6: When syrups are used in something other than beverages.

ABC Distributing distributes sweetened beverages to a restaurant in Seattle. The distribution consists of bottles of flavored syrups that the restaurant utilizes for their dessert creations or as an ingredient in other non-beverage items.

Question 1: Are the syrups subject to the SBT?

Generally, bottles of flavored syrups would be subject to the SBT because based on the manufacturers’ instructions they are to be used to make sweetened beverages. The restaurant, however, uses these for creating desserts. Therefore, these syrups may be excluded from the SBT.

Question 2: What documentation does the distributor need to obtain from the restaurant if it wishes to exclude the syrups from the SBT?

Answer: The distributor will need to obtain documentation from the restaurant operator that the syrups purchased are not used to create sweetened beverages but are intended for other purposes. For example, the distributor may secure from the restaurant a written statement that clearly provides those specific syrups are not used for sweetened beverages but instead are used in the production of certain meal items. The document should be signed by an individual authorized to sign off on tax matters for the restaurant. The distributor will need to retain this signed statement as documentation for the syrups it excluded from the SBT in this instance. If the distributor does not obtain documentation from the restaurant operator, then they should remit the SBT on the distribution of the flavored syrups to the restaurant.

EXAMPLE 7: When syrups are used in milk-based drinks.

LM operates a coffee shop in Seattle. ABC Distributor distributes 50 bottles of syrups to LM in Seattle for use in its coffee drinks.

Question 1: Who is liable for SBT in this instance?

Answer: ABC Distributor is liable for the SBT.

Question 2: What if LM determines that approximately 25 bottles of the syrups will be used to make coffee drinks in which the primary ingredient is milk?

Answer: If LM provides ABC Distributor with documentation stating that the 25 bottles of syrup are used to create drinks in which the primary ingredient is milk, ABC may exclude the 25 bottles from the SBT. The ABC may secure from LM a written statement that clearly provides those specific syrups are used for beverages in which the primary ingredient is milk. The document should be signed by an individual authorized to sign off on tax matters for LM. ABC will need to retain this signed statement as documentation for the syrups it excluded from the SBT in this instance. If ABC does not obtain documentation from LM, then ABC must remit the SBT on the distribution of the flavored syrups to LM.

EXAMPLE 8: When a restaurant’s custom drink recipe differs from a manufacturer’s instructions.

JM is a restaurant chain with locations in Seattle. JM purchases syrups from EZ Distributing. JM, however, does not use the syrups under the manufacturers’ instructions. Instead, JM uses multiple syrups for its own custom drink recipes and as a result, one drink has approximately 4 ounces of different syrups per 12-ounce drink. Therefore, based on its recipes it can only produce an average of 75 ounces of sweetened beverage from one bottle.

Question: Is EZ required to follow the manufacturers standard in determining the SBT due on the distribution to JM?

Answer: SMC 5.53.030.A.2 specifically allows for the SBT to be calculated proportionately so that the combined tax when using multiple concentrates yields $.0175 per whole fluid ounce of the resulting beverage. JM may provide documentation to EZ Distributing showing that it does not use the syrups as instructed by the manufacturer, detailing in its declaration to EZ that an average drink uses 4 ounces of syrup per drink, rather than 2 ounces. Without such documentation, JMs use would make the syrup taxable at $0.0353 per oz. ($2.625 / 75 beverages per bottle average) rather than $0.0175 per oz. ($2.625 / 150 sweetened beverages per bottle).

However, EZ may instead pay the SBT on the distribution of syrups to JM based on JMs use of 4 ounces of syrup per a 12-ounce sweetened beverage, meaning each bottle can create approximately 75 ounces of sweetened beverage, making the SBT on one bottle $1.3125. Therefore, EZ will be liable for $131.25 of SBT on the distribution of syrups to JM. EZ is required to maintain in its records the declaration from JM detailing its use of the syrups to support its tax calculation on the distributions to JM.

DOWNLOAD THIS FACT SHEET FOR FUTURE REFERENCE

ADDITIONAL RESOURCES

City of Seattle Sweetened Beverage Tax Page: www.seattle.gov/business-license-tax/other-seattle-taxes/sweetened-beverage-tax

City of Seattle Sweetened Beverage Tax Rule: http://clerk.seattle.gov/~scripts/nph-brs.exe?s1=5-953.NUM.&l=20&Sect6=HITOFF&Sect5=BTXN1&d=BTXN&p=1&u=/~finance/btxn1.htm&r=1&f=G

City of Seattle Sweetened Beverage Tax Contact: SweetenedBevTax@seattle.gov

Keep Seattle Livable for All: www.keepseattlelivableforall.com

Keep Seattle Livable For All is a coalition of concerned citizens, businesses and community organizations actively opposing new taxes on everyday items like juice drinks, diet beverages, sodas, teas, sports drinks and ready-to-drink coffee beverages. If you would like to engage in their efforts, you can sign up for their coalition through this link.

~ politics petitions pollution and pop culture

THE SENATE Jan2-4 CONGRESS 2018 THE HOUSE

01/05/2018 Nativegrl77 2 Comments

	Wrap Up for Thursday, January 4, 2018
January 3, 2018	Wrap Up for Wednesday, January 3, 2018
January 2, 2018	Wrap Up for Tuesday, January 2, 2018

Last Floor Action: Jan. 3rd
12:03:01 P.M. – The Speaker announced that the House do now adjourn pursuant to section 4(c) of H. Res. 670. The next meeting is scheduled for 12:00 p.m. on January 5, 2018.

11:00:04 A.M.		The House convened, starting a new legislative day.
11:00:10 A.M.		The Speaker designated the Honorable Patrick T. McHenry to act as Speaker pro tempore for today.
11:00:30 A.M.		Today’s prayer was offered by the House Chaplain, Rev. Patrick J. Conroy.
11:01:30 A.M.		SPEAKER’S APPROVAL OF THE JOURNAL – Pursuant to section 3(a) of H. Res. 670, the Journal of the last day’s proceedings was approved.
11:01:42 A.M.		PLEDGE OF ALLEGIANCE – The Chair led the House in reciting the Pledge of Allegiance to the Flag.
11:02:33 A.M.		The Speaker announced that the House do now recess. The next meeting is subject to the call of the Chair.
11:55:23 A.M.		The House convened, returning from a recess continuing the legislative day of January 3.
11:55:47 A.M.		The Speaker announced that the House do now adjourn Sine Die.
12:00:00 P.M.		The House convened, starting a new legislative day, pursuant to the 20th Amendment to the Constitution for the meeting of the second session of the 115th Congress.
12:01:00 P.M.		The Speaker designated the Honorable Patrick T. McHenry to act as Speaker pro tempore for today.
12:01:00 P.M.		Today’s prayer was offered by the House Chaplain, Rev. Patrick J. Conroy.
12:01:00 P.M.		PLEDGE OF ALLEGIANCE – The Chair led the House in reciting the Pledge of Allegiance to the Flag.
12:02:00 P.M.		The Chair announced that pursuant to section 4(a) of H. Res. 670, no organizational or legislative business will be conducted on this day.
12:02:40 P.M.		The Chair announced that bills and resolutions introduced today will receive a number but will not be referred to committee or noted in the Record until a subsequent day. The Chair also announced that executive communications, memorials, and petitions likewise will be referred and numbered on a subsequent day.
12:03:01 P.M.		The Speaker announced that the House do now adjourn pursuant to section 4(c) of H. Res. 670. The next meeting is scheduled for 12:00 p.m. on January 5, 2018.

~ FDA/USDA ~~ Alerts & Safety

FDA/USDA ~January Alerts & Safety

01/04/2018 Nativegrl77

As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which 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.

Consumers should not consume these products. No illnesses have been reported in connection with the recalled items

Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

Updated information is now available. The list of retail consignees has been posted for recalls: 123-2017, Trafon Group Recalls Chicken and Pork Products Produced Without Benefit of Import Inspection (Nov 16, 2017)
Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have 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 system. 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 in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.This coconut products were distributed in Ohio, Massachusetts, Washington, California, Oklahoma, Illinois, Michigan, New Jersey and New York. This Frozen Shredded Coconut product is package in 16 ounces plastic bags. This recall is limited to Lot SE07A1, but the lot number is only printed on the case. Therefore, any customer that purchased this product from January 3, 2017 through January 3, 2018, should return the product to place of purchase for full refund. Customers may also contact Evershing International Trading Company at (408) 975-9660 during hours of operation, Monday to Saturday from 9:00 am to 5:00 pm.
The issue was discovered by testing performed by the State of Massachusetts.

This voluntary recall is being made with the knowledge of the US Food and Drug Administration. We appreciate your assistance in this matte. Although these products are not ready-to-eat items and have baking instructions which, if followed, will reduce consumer risk, there remains some risk that the mishandling of this product prior to or without adequate baking may cause illness.

We are working in coordination with the Food and Drug Administration (FDA) and our supplier on this recall.

All affected distributors and retail customers are being notified and the affected products are being removed from store shelves.

Affected product should be destroyed or may be returned to the place of purchase for a full refund. Consumers with questions may contact 1-866-837-2758 between 8 a.m. and 5 p.m. Eastern Time.

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

Risk Statement: The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

The product Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intraabdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older. The affected Ampicillin and Sulbactam for Injection lot being recalled is AFO l 17001, EXP. December 2018. It is packaged in a carton containing 10 vials, NDC: 55150-116-20. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide on February 9, 2017.

To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product. Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952, Monday through Friday from 8:30 AM to 5:00 PM EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

ISSUE: The Agilis Steerable Introducer Sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
- Model numbers and lot numbers: STJ408309, STJ408310, STJG408324; All product lots
- Manufacturing and Distribution Dates: January 1, 2017 to May 5, 2017
The use of affected products may cause serious health consequences for patients, including death.

BACKGROUND: The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum).

The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.

RECOMMENDATION: Sterilmed has provided the following instructions for health care facilities and providers:
- Examine inventory immediately to determine if you have this product.
- Do not use any of the affected products, and return any unused product to the company.
- Share this information with the appropriate staff at your facility.
- Continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal.
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

~ politics petitions pollution and pop culture

Why is catherine running as a Democrat? #staywoke

01/04/2018 Nativegrl77

Ruben got an opponent,Catherine Miranda Here’s the part you won’t believe, she’s running as a Democrat.

She endorsed Republicans Doug Ducey for Governor and Michele Reagan for Secretary of State
She’s received hundreds of thousands of dollars in support from corporate dark money, including groups linked to the Koch Brothers
She signed the “Pro-Life Pledge” committing to a radical anti-choice agenda

Ruben is eager to have an opportunity to demonstrate the difference between a progressive fighting for working people and an anti-choice, corporate-sponsored politician who endorsed Ducey and stood by while he gutted public education.

But to do that, we need to rally support behind him right now.

We’re ready for this fight.

We know you’re with us,

— GallegoforArizona.com