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[IP] FDA notice on H-TRONplus V100 Infusion Pump



>From: "Dr. Joe, The Diabetes Doctor" <email @ redacted>
>To: (Recipient list suppressed)
>Subject: E-News 08/23/01
>Date: Thu, 23 Aug 2001 01:50:00 -0700
>
>This information was sent to me to be forwarded on.
>
>Dear Joe,
>
>The FDA recently published the attached notice on one of their web sites:
>
>http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html
>
>RECALL NUMBER, PRODUCT AND CODE: Z-709-1, H-TRONplus V100 Insulin Infusion
>Pump, All Serial Numbers REASON: Misbranded in that there are labeling
>claims of the H-TRONplus V100 Infusion Pump being waterproof; however, this
>claim was not clear. MANUFACTURER/RECALLING FIRM: Disetronic Medical
>Systems, St. Paul, MN RECALLED BY: By letter dated March 14, 2001 FIRM
>INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: Estimated 
>30,000
>
>We want to let you and any visitors to your site that may be concerned by
>this notice know that it refers only to Disetronic's March 14, 2001 patient
>notification letter and reference manual supplement regarding use of H-TRON
>and H-TRONplus insulin pumps in water. This action was a voluntary action
>by Disetronic. The FDA defines this action as a "field correction" which
>involves the "repair, modification, relabeling...of a device without its
>physical removal from its point of use..." H-TRON and H-TRONplus pumps are
>not being replaced or removed from the market by this action. This is old
>news and we don't want customers to be alarmed.
>
>Sincerely,
>Rem Laan
>Director of Marketing
>Disetronic Medical Systems, Inc.
>
>
>Dr. Joe, the Diabetes Doctor


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