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Topic Title: RECALL on Johnson and Johnson Animas 2020 pumps manufacturred between Mar-Nov 2012
Created On: 04/09/2013 03:45 PM
 
 04/09/2013 03:45 PM

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FatCatAnna

[size=font-family: verdana, geneva; font-size: small;]This was issued on April 6, 2013 - and has been designated as a Class I recall, which is the most serious of designations and indicates that use of the recalled device could lead to serious injury or death.[/size]

[size=font-family: verdana, geneva; font-size: small;]The following was taken from the [url=http://www.publichealthwatchdog.com/johnson-johnson-animas-unit-recalls-insulin-pump/]Public Health Watchdog[/url] - [/size]

[size=font-family: verdana, geneva; font-size: small;]" The defect may lead to unintended insulin delivery, said Fierce Medical Devices, and prompted the U.S. Food and Drug Administration (FDA) to deem the move a Class I recall, its most serious designation and one that indicates that use of the recalled device could lead to serious injury or death.[/size]

[size=font-family: verdana, geneva; font-size: small;]Animas 2020 pumps were manufactured from March 2012 to November 2012 and were constructed with a defective component that can cause faulty alarms and that also prompt patients to rewind, load, and prime the device, which can lead to unnecessary infusion, said Fierce Medical Devices. This can place patients at risk for hypoglycemia. Also, said Animas, the pumps have a software defect that renders them unusable effective December 21, 2015. "[/size]

[size=font-family: verdana, geneva; font-size: small;]If you wish more information - go to this link at the [url=http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm]FDA[/url] - which explains how to proceed with reporting your insulin pump if it was manufactured during these dates.

What urkes me is how Ms. Pavis, like she did with my questions - just gives the answer that it's really nothing - as you can see in the Animas Corporation announcement on April 8th, 2013 - a few days after the FDA notice above .... [url=http://www.animas.com/sites/default/files/pdf/FDA%20Classifies%20Previous%20Field%20Action%20of%20Animas%202020.pdf]http://www.animas.com/sites/default/files/pdf/FDA%20Classifies%20Previous%20Field%20Action%20of%20Animas%202020.pdf[/url]

Of course, they mention that friggin software defect that I've been writing about since December - I hate being reminded about my little George Michael (here's a pic that I tried to load up in my post - but had some probs uploading ... [url=http://twitpic.com/ci7l19]http://twitpic.com/ci7l19[/url] ) that is sitting still in his little zip lock bag since January.

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