Anna, my friend Mary forwarded an email someone she knows got from Animas. Someone just commented on my blog that she received a letter from Animas. I also looked on the FDA site and did not see it there either.
I believe that Lot B201596 (sold in Canada) is also defective - or at least I have found them to have leaked insulin into the pump resevoir.
If you have a cartridge from this lot you will know if your cartridge is leaking if you disconnect the infusion set from your body, remove the cartridge and smell any insulin in the resevoir. The Animas rep asked me to do this and the smell of insulin in the resevoir area was quite powerful, and so it is likely that the cartridges have leaked and are thus defective.
If you have cartridges from this lot, and if your sugars have been out of control lately, you may want to check to see if you have cartridges from the same lot and do the sniff test as described above (don't forget to remove the infusion set from your body and then do the whole prime/rewind routine before reconnecting the infusion set to your body).
If you smell insulin, call Animas (the number for Canadians is 1-866-424-6779 - the number in the US is 1-877-937-7867), and inform them of your findings so that they can send you new cartridges.
Animas handled my inquiry quite well. They are going to send me new cartridges to replace the ones I have from that lot, and they are going to send a post-paid courier envelope for me to send them the defective cartridges so that they can run a few tests on them.
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