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Crédits
Devices
Device Recall Disetronic
Modèle / numéro de série
Lot 3H003UF.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
1 Event
Rappel de Device Recall Disetronic
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Fabricant
Disetronic Medical Systems, Inc.
Adresse du fabricant
Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
Source
USFDA
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Device Recall Disetronic DTron
Modèle / numéro de série
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.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide.
Description du dispositif
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
Modèle / numéro de série
Lot 3G039UF.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
Modèle / numéro de série
Lot 3J012UF.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
Device Recall Disetronic
Modèle / numéro de série
Lot 3H067UF.
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only).
Manufacturer
Disetronic Medical Systems, Inc.
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