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Re: [IP] Deltec Cozmo Recall # Z-0798-03



On 6/17/03 1:05 AM, "Bob Lucid" <email @ redacted> Demonstrated stellar typing
skills  and mental acuity by writing:

> Hi all!
> 
> FDA initiated a recall of the Deltec Cozmo.
> Have a look for "Deltec" on this very long FDA page:
> <http://www.fda.gov/bbs/topics/enforce/2003/ENF00797.html>
> 
> Did you already send back your pumps?
> Is the software error mentioned only a theoretical one or do you experience
> it every day?
> 
> I was always interested in the Cozmo,but now I doubt whether or not to trust
> it!
> 
> Regards, Bob

Gee, Paul, From what I read there the company did.

PRODUCT 
Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01,
21-1712-01    and 21-1713-01. The 3 versions vary only in the color of the
exterior. Recall    # Z-0798-03.
CODE 
All units distributed since product introduction in December 2002 are
involved. 
RECALLING FIRM/MANUFACTURER
Deltec, Inc., St Paul, MN, by letters on March 14, 2003. Firm initiated
recall    is ongoing.
REASON 
A software error can result in the delivery of a larger bolus of insulin
than    anticipated when the pump is programmed in a particular manner.
VOLUME OF PRODUCT IN COMMERCE
913 pumps. 
DISTRIBUTION 
Nationwide. 

-- When you are dissatisfied and would like to go back to youth, think of
Algebra.

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