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Old 12-27-2005, 02:56 PM
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Kaylie Kaylie is offline
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Hi everyone,
Â* Â* Â* Â*I have been writing and calling many different agencies in regards to the shiley crisis,especially since hearing so many conflicting different reasons why we dont have or cant get the trachs. So many stories and so much who knows what, i just wanted to find the Â*real reasons why. Today i spoke with the FDA, One of them being the gentleman who wrote the warning and violation letter about shiley, and then another woman as well. It being the holiday season and staff is short it will take them sometime to get back with me in regards to specific ? Sterilization,sanitation,plant shutdown,recall, but he does remember the letter . I also too spoke with a shiley rep in regards to the trach as well as our really wanting to find out whats going on, she said it was voluntary shut down to revise Â*some areas. she specifically said there was not a sterilization or recalls or anything.i will wait for a call back from the other people and let you guys know,but i gotta get of now its time for the nurse to go home. thanks
Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Â* Kathy
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Old 12-27-2005, 03:33 PM
hcs_mom hcs_mom is offline
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I can't believe you talked to the man who wrote that letter...that's awesome. Please let us know when you hear back from them. I am very curious to know WHY they are not producing trachs and to see if the reason the makers of Shiley gives you matches any info you get from the FDA.

You know, if the manufacturer had just been honest about this, even posted a notice on their website, this would have been soooo much easier.

I find it hard to believe that this stop in production was voluntary...especially considering the warning letter that was sent last year.

Jennie
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Mommy to Hannah 8/2/03: fmr 25-weeker, trached 11/03 for subglottic stenosis, LTP 4/05, CTR 4/06, LTP 1/07. Decannulated 1/19/2007!! Gearing up for reconstruction #4; Also Mom to Brianna, 2/22/98: fmr 24-weeker, a little dramaqueen. My amazing gifts.
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