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Devices
Device Recall Disetronic
Model / Serial
Lot 3H067UF.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
1 Event
Recall of Device Recall Disetronic
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Manufacturer
Disetronic Medical Systems, Inc.
Manufacturer Address
Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
Source
USFDA
4 devices with a similar name
Learn more about the data
here
Device Recall Disetronic DTron
Model / Serial
All units with the following lot numbers being used by patients 13 years of age or younger: lots 4013674 through 4022628. The last affected lot expires in April 2007.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Manufacturer
Roche Diagnostics Corp.
Device Recall Disetronic
Model / Serial
Lot 3H003UF.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
Model / Serial
Lot 3G039UF.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
Model / Serial
Lot 3J012UF.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
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