FDA and DOJ tag team Spectranetics Corporation

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The following is a textbook example of why you don’t want to cross the FDA. Not only are they the most underrated heavyweights around, they’re also best buddies with The Justice Department. And together, they can bring the pain. Big time.

Spectranetics Corporation, a Colorado Springs medical device manufacturer, allegedly “…illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.”

It apparently wasn’t small level stuff like gauze or bandages that were illegally brought over, either.

“The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.”

Whoops!

So now after a quick tag-team match with the DOJ and FDA, Spectranetics now “…has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company.”

There were no criminal charges filed against Spectranetics, even though they “caused false claims to be submitted to the Medicare Program during portions of the time period from 2003 to 2008.”

And as part of the no criminal charges deal, “Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation.”

Here’s the link to the DOJ article.

WordPress for the iPhone, “500” errors, .htaccess, and 1&1 hosting

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Thanks to Jeremy Snyder’s website, I finally got WordPress for the iPhone up and running.

1&1 hosting needed…

AddType x-mapp-php5 .php

…added to my .htaccess file.

So now this blog is (finally) fully mobile!

Here’s the link to the repair article on snydersoft.com.

Recall : The entire “Thermoflect” product line used in MR environments

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The Encompass Group announced they are voluntarily recalling the entire Thermoflect product line. This product was used in MR (Magnetic Resonance) environments, but is being pulled back for “relabeling”.

Encompass Group Corporate Compliance Officer Jea R. Gackowski said “”We are requesting that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. We are in the process of sending labels to our customers to be attached per instructions to remind the hospitals that the product line should not be used in the MR environment.”

Wait… what? Thermoflect blankets and covers were used in MR (Magnetic Resonance) environments before, and now they’re suddenly not?

Gackowski said that in the past they stated their Thermoflect product was indeed OK to use in MR environments, and their product is still great for treating hypothermia, but “…we have been advised by the FDA that a report has been filed of an injury to an (MRI) patient.  Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one.  There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure we are voluntarily recalling the product line for relabeling.”

Yikes. I smell a lawsuit. A big, nasty one too. And the Encompass Group is implementing plan “CYA”.

Here’s the link to the FDA notice.

200th post!

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Just a little personal milestone here… this is the 200th post in this blog!

I remember as a kid that “issue 200” of my favorite comics usually meant something spectacular was about to happen. Some crazy new adventure would begin, some major character would get added or taken out of the storyline, or most thrilling and terrifying of all… a new writer and/or artist would start work on the next issue of the comic.

I’m still messing around with what goes where in this blog, but things are finally settling into a somewhat stable pattern. My sincere thanks to everyone who has been reading along this whole time!

And now, thanks to CoverBroswer.com, some “200th issue!” eye candy from my childhood…

Recall : Tylenol Arthritis Pain 100 Count With Ez-Open Cap

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Fortunately, this is not a medical-emergency recall.

“McNeil Consumer Healthcare… is expanding its voluntary recall to include all available product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP.”

Some of the Tylenol Arthritis Pain 100 Count With Ez-Open Cap shipments were pulled back earlier because some customers said that when they opened the bottle, they got… “an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea.”

But it’s not the capsules that are causing the cookie-tossing side effects.

“The uncharacteristic smell is caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.”

But still, the last thing you want when you have a headache or body ache is to add nausea, stomach pain, vomiting and diarrhea to the mix.

Only Tylenol Arthritis Pain Caplet 100 count bottles with the red ez-open cap are affected.

UPC # : 0045-0838-21
NDC Code: 8382100
Lot # : 07CMC011, 07DMC022, 07DMC024, 07FMC032, 07FMC033, 07GMC038, 07GMC039, 07HMC045, 07HMC051, 07HMC053, 07JMC064,  07JMC069, 07JMC070, 07JMC071, 07XMC055, 07XMC058, 07XMC062, 08AMC002, 08AMC005, 08CMC026, 08DMC029, 08EMC037, 08EMC039, 08FMC044, 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065, 08JMC103, 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131, 08KMC132, 08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041, 09EMC075, 09EMC079, 09EMC076, 09GMC096, 09GMC097, 09GMC099, 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114, 09XMC116

Here’s the link to the official FDA recall.

AT&T says “you don’t have enough towers”

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This was too good not to immediately post this morning.

According to an article on the consumerist, AT&T is no longer selling iPhones in New York City. You know… the New York City? One of the greatest cities in the United States?

When the Consumerist went online with AT&T customer service to find out why, they were told by a rep named Daphne… “I am happy to be helping you today. Yes, this is correct the phone is not offered to you because New York is not ready for the iPhone. You don’t have enough towers to handle the phone.”

AT&T is not even trying anymore. They actually have the unmitigated balls to tell a customer that it’s their fault there aren’t enough towers in their city. Instead of getting off their duff and fixing their network, they’re restricting sales to new, paying customers… customers who want to buy their product… because their busted-ass network is past their capacity to manage.

“You don’t have enough towers to handle the phone.”

I think AT&Ts solution to the problem will be to fire Daphne, then issue a press release to say “we’re striving to be the best and will continue to do everything we can to be the best because we are the best at talking about what’s the best… blah blah blah.”

AT&T’s pinhead managers apparently decided not to let anyone else into their network because they’re past the maximum threshold their ancient system can handle, so they’re done with that city. And by proxy, so is the iPhone.

Hey Apple / Steve Jobs. You might want to review your contract with these idiots to see if there’s something in there you can hammer them with. Because, quite frankly, if you don’t do something about this, every other cellular carrier is going to notice you don’t mind when someone walks all over you and smacks you around a bit. And think of it this way, too… do you think Microsoft (under Gates or Ballmer) would stand for a fraction of this treatment from their partners? Ask yourself, What Would Microsoft Do if this was happening to them?

Time to unleash the hounds and get some respect back.

Monday Morning Music : 12/28/09

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Every Monday I’m going to start posting some music to start the week off on the right foot.

The last Monday Morning Music post for 2009? A little surreal jam… The Avalanches – Frontier Psychiatrist. (Think Oingo Boingo and Primus getting together after a four day weekend bender.)

Christmas Break!

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I’m going to take the rest of the week off, so there will be no new posts until Monday. (Well, unless it’s really really necessary.)

Hope everyone has a very happy, safe and very Merry Christmas!

Price Check : Sams Coca Colas

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Here’s another example of some quick math saving a little money.

I was at Sam’s getting some tasty beverages for the weekend. I got to the Coca Cola section and was about to grab a tray of cokes. There was a “4/8 pack” and a “24” pack selection.

I have no idea why Sam’s has one set of coca colas listed as a “4/8” pack. 8*4=32. So really it’s a 32 pack or a 24 pack. They’re the same 12oz cans, just in different packaging and different quantities.

Sams Coca Colas A

Sams Coca Colas A

The 32 pack was for $9.84. That works out to about .31 cents each.

Sams Coca Colas B

Sams Coca Colas B

The 24 pack was for $5.98. That works out to about .25 cents each! A .06 cent difference per can!

Even though you get fewer 12oz colas in the 24 pack, you get a lot more for your money if you buy the 24 pack. Especially in multiples. If you needed 96 coca colas for a big birthday party, 3 of the 32 packs would cost you $29.52. While 4 of the 24 packs would cost $23.92. That would be a $5.60 difference for the same number of colas in different packaging.

Price Check : Razors

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It’s pretty easy sometimes to figure out what’s a better deal on some items. A simple price check often saves me a lot of money.

Take for example razors. It was time to get another set, so I went to the local Target to grab a few.

Now I have both Gillette and Schick razor handles, so the brand of razor doesn’t restrict me. It was just a matter of finding out which blade refills were going to be more affordable. First up, on the endcap of the isle, I found this…

Price Check - Razors 01

Price Check - Razors 01

For $8.99, I get 6 razor blades (counting the one on the razor blade handle), 4 AAA batteries, and a set of “portable speakers”. That works out to $1.50 a razor blade. ($8.99/6) Not bad! Plus it’s the multi-blade system I like. Plus I get free batteries!

But maybe this wasn’t the best deal. I took a walk down the “regular” isle of razor blades and was almost floored…

Price Check - Razors 02

Price Check - Razors 02

$15.09 for 4 razor blades?!? That’s $3.77 each! Even with a mini mini bottle of shaving cream/shampoo stuff, that’s still way too high. Maybe in a different quantity?

Price Check - Razors 03

Price Check - Razors 03

Nope. $24.99 for 8 razor blades works out to $3.12 each. $35.99 for 12 razor blades works out to $2.99 each. Still too high. And I don’t get anything “extra” either.

The gift set won, hands down.

This gift set was the only one left at this Target store, but I’m going to be on the lookout for more of these sets in the next few days and stock up.

Goofy as it sounds, a little math does go a long way.