Wednesday, June 18, 2014

Fwd: FDA MedWatch - Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

---------- Forwarded message ----------
From: FDA MedWatch <fda@service.govdelivery.com>
Date: Wed, Jun 18, 2014 at 9:24 AM
Subject: FDA MedWatch - Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
To: iammejtm@gmail.com

Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

AUDIENCE: Risk Manager, Pharmacy

ISSUE: Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Hospira has attributed the embedded particulate to a supplier's glass defect. Hospira is working with its supplier on implementing corrective and preventive actions.

Administered solution with particulate - depending on the particle size and number - could block administration of the drug to the patient, causing a delay in therapy. Particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

BACKGROUND: Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals and clinics nationwide.

RECOMMENDATION: Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-888-656-6380 (M-F, 8 a.m. - 5 p.m. ET).

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401724.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

--
Jeremy Tobias Matthews

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Custom Quality Promise

Riding Of The Practical Knowledge Through The Moves Done Up Ahead; Up River In The Visualization Of River Boarder Moves Being Done. One Should Fit The Shape That's Going To Steer Through The Rapids Accurately In Order To Make The Sport Safer And Better. It Is True That This Sport Is Beyond All Of Us Inspiring All Of Us River Boarders To Champion The Charge Up River In The Uplifting Of The Human Spirit, Therefore To Instance Such Self Reliance In Action By Shaping And Self Propelling In Roaring Rapids That Are Deep Enough Where The Rider's Wise Enough To Navigate With Some Custom Steering Edges By A River Boarder Capable Of Eyeing The Spot To Ride In. The Set Up Should Also Be Customized For Each Spot The Rider Is Going To Ride In. Any One Size Fits All Is Inaccurate When Dealing With Multiple Gaps Of A Set Of Rapids With Skimming Spaces On Either Side Wherefore Knowing Where All Of The Rocks Are At Is As Important As Is Where To Mix And Match The Handle System, The Board And Set Up To Fit What Gap In The Rapids You Want To Start From In The Ride Up River. All Shapes Are Available In Foam Composite Or Wood, Just Tell Me Which Shape As Well As Color Of Edges, Background, What Creature and Color Of It.

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Safety Guidelines And Liability Release

1. Do Not Attach Rope Or Board To Yourself

2. Do Not Attach Metal To Board Or Set Up

3. Be Alert And Give Right Of Way To River Traffic

4. Do Not Leave Board Unattended In Water

5. Do Not Detach Set Up From Shore With Board In Water

6. Do Not Attach Set Up To Branches Of Trees

JTM RAPID BOARDS Warrants That They Are Not Liable And May Not Be Sued Against The Law For Personal Injury Caused By The Misrepresentation Of The Abilities To Have What It Takes To Handle This Sport, Nor Will They Be Blamed For Any Environmental Damages An Inexperienced Rider May Cause To His Or Her Own Board Or Set Up.

Knowledge Empowerment And Coaching

Here's What We Are Talking Here As Far One On One Lessons Being Procured For Sound Judgement Of River Safety And High End Athletic Display To Get To A Professional Level Of River Boarding Where The Rider Is Doing, An Actual Repertoire Of River Boarder Moves. It Is Fully Understood That Not Everyone Grew Up Swimming In A River And Is Prepared For Anything That Can Happen On One, That's Why We Have JTM A.K.A Jeremy Tobias Matthews River Boards. A Subsidiary Of River Ruler Entertainment. A Film And Music Production Label. Wether I Am Training You To Be A Future Franchise Owner Or Just So You Can Teach Your Own Children The Rate Is $90 An Hour Happy To Be Of Service Just Set An Appointment If You Need Me. See Also River Board Group Rate Lessons In The Search Box To To See Group Rate Lessons Before Setting An Appointment.

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Quality And Service

The Soul Of The Sport Of River Boarding Is Connecting To The Specific Rapids We Ride In Through Working With Our Hands And Our Feet And So Moving To Moving Through With The Follow Through JTM Rapid Boards Hereby Discloses That Upon Receiving An Email Request For Order Form And Going Through The Email Exchange Estimate Process The Following Will Occur: The Rider Will Get The Exact Custom Board Made By Hand That They Want Within Two Weeks After We Have Received A Check Made Out To The Shaper By Hand To Jeremy Matthews(See Contact Info).

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Stretch Technician Services

The Art Of The Stretch System Is To Get The Stretch The Same Consistency As The Current To Ride In So The Rider Is In Balance With The River. This Is A Lot Less Strain On The Body. It Also Makes For A Smooth Even Pull Up River With No Jerks Or Sudden Stops. Since Every Riding Spot Is Different The Professional Rider Has Different Length Segments To Match Different Spots. Therefore For The Safety Of Customers The Rider Should Know How Many Gaps They Want To Charge Up Into And How Deep The Water Is. The Shop Rate For Making A Set Up Is $40 An Hour Tie Off Instructions Included With Purchase. Please Set An Appointment For Estimate.

A3 Description

A4 Description

Overall This One Is Shaped Like An Otter However This One Does Have A Tendency To Get Caught In A Dive If The Rider's Weight Is Not Kept On The Back End To Prevent The Current From Taking The Nose To The Bottom So The Rider Must Adjust When Caught In a Dive. Don't Just Let It Go. You Will Just Have To swim To The bottom To Get It Anyway. You Might As Well Adjust Right Then And There And Put Weight On The Back End Of The Board While Your Exploring Underneath The River. It Does Have A Split Tail On The Rear Which Makes For Nice Rail To Rail Banking. It Also Has The Inverted Center So You Can Carry It Under Your Arm Like A SurfBoard With The Same Length As A3.

A5 Description

One Of The Things I Love About This Shape Is The Diversity Of Tricks It Allows. A Skilled Rider Can Do Any Trick On Any Shape Granted, But Some Tricks As A Shaper Has A Certain Shape In Mind, Just Work Better For Those Tricks. That Is Why A Good Shaper Rides The Boards They Make And Visualizes The Moves They Will Do Within The Movement And Bodily Timing With The Rapids Before They Make The Shape They Ride And So This Is The One That This Rider Can Do The Most Tricks Under The Water, On The Water And Above The Water With To Begin With, And Then Once The Tricks Are Mastered They Can Be Done On Any Board. Some Boards Will Work Better For Different Body Types So Knowing Your Own Body Is The first Step And Knowing The Tricks And Spot Come Next. Trust Yourself You Will Always Do That The Best.

Wednesday, June 18, 2014

Fwd: FDA MedWatch - Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

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