Recall: Nationwide Recall Of All Accu-Chek Ultraflex Infusion Sets

[babylonsister]

Recall: Nationwide Recall Of All Accu-Chek Ultraflex Infusion Sets

Just in case any of you are diabetic, or have someone close to you that uses this.

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Recall: Nationwide Recall Of All Accu-Chek Ultraflex Infusion Sets

April 2006 - Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind. announced (April 3, 2006) a voluntary nationwide recall of all ACCU-CHEK Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

http://thediabeticnews.com/news/915.shtml

[SpeedwayDemocrat]

1. But - they say it's NOT a recall...

Yeah, right! I just got off the phone with them, as I am a user and have a full box of these lame suckers left. I never had a problem with them when they were manufacturered by Disetronic; 2 years of daily usage with no failures. Once they slapped an Accu check logo on them, I had four of them fail in less than 4 months. All failed at the same spot and without any twisting or tugging - the tube just separated from the plastic Luer lock. If it wasn't for the smell of insulin, I would not have known. I started reporting the problem to my endocrinologist, who filed the issue reports with the Feds. Finally, someone took some action - but it wasn't Accu-chek or their parent Roche!

According to the rep I just spoke with, they are not recalling them. "As long as you check them EVERY 3 HOURS without fail, you can use them!" When I pressed them for a replacement, he said they would either swap them out for one of their two other models, neither of which is the same (one uses a slant insertion cannula and the other leaves a METAL cannula inside you ICK)

By the way - they WILL NOT CONTACT YOU DIRECTLY and you won't get a warning letter about the problem either. How did I find out? An e-mail this morning from a class action law firm's newsletter! Way to screw those loyal users!
I'm shopping for other manufacturers of infusion sets, as the Roche response is lame at best. Without insulin, I'm DKA in 6-8 hours and dead inside of 24. I can't afford another failure, as every trip to the hospital for DKA is $9,000! PLEASE - Everybody spread the word about this issue, as Roche sure isn't going to...