[Previous Months][Date Index][Thread Index][Join - Register][Login]
  [Message Prev][Message Next][Thread Prev][Thread Next]

RE: [IP] Recall of Disetronic Infusion Pump - ALL MODELS April 2003



"Denise Owens" <email @ redacted> wrote:
> http://www.fda.gov/bbs/topics/enforce/2003/ENF00791.html

Cutting the relevent info from the above URL.  The only entry about
Disetronic is:

-----
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_________________________________
PRODUCT
Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and
8100005 D-TRON (anthracite). Recall # Z-1350-02. This correction was
previously classified as a Class II. The health risk was reevaluated after
receipt of new information.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Disetronic Medical Systems, Inc. St. Paul, MN, by letter
dated June 17, 2002.
Manufacturer: Disetronic Medical Systems AG Burgdorf, Switzerland. Firm
initiated recall is ongoing.
REASON
Some pumps started programming a bolus that was not initiated by the pump
user, and the delivery of an unintended bolus was made unless interrupted by
the device user.
VOLUME OF PRODUCT IN COMMERCE
3357 insulin infusion pumps.
DISTRIBUTION
Nationwide.
-----

That is NOT "ALL MODELS".  That's a re-classification of an existing,
ongoing recall.  Most (all?) of us who did have the affected pump (DTron)
have received our replacements (DTron+) by now.  I've had mine for over a
month, and love it -- there are quite a few subtle improvements.


--Greg
----------------------------------------------------------
for HELP or to subscribe/unsubscribe, contact:
HELP@insulin-pumpers.org