Devices

Device Recall AccuChek

  • Modèle / numéro de série
    Lots 2J081UF, 2J066UF, 2K032UF, 2K050UF, 2K057UF, 2L009UF, 2L079UF, 3A002UF, 3A028UF, 3B011UF, 3C047UF, 3D139UF, 3F074UF, 3F084UF, 3F117UF, 3G025UF, 3G039UF, 3G064UF, 3G084UF, 3G151UF, 3H026UF, 3H034UF, 3H058UF, 3I117UF, 3J048UF, 3K001UF, 3K084UF, 3L079UF, 4A107UF, 4A116UF, 4C133UF, 4C153UF, 4C156UF, 4D133UF, 4E118UF, 4F005UF, 4F135UF, 4F180UF, 4G159UF, 4H066UF, 4H149UF, 4I048UF, 4J004UF, 4J148UF, 4K065UF, 4L079UF, 5B005UF, 5C191UF, 5E070UF, 5F148UF, 5G187UF, 5I092UF, 5I204UF, 5J195UF, 5K027UF, 5L005UF and 6B078UF..
  • 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
    Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
  • Manufacturer
    Disetronic Medical Systems, Inc.
  • 1 Event

Fabricant

Disetronic Medical Systems, Inc.
  • Adresse du fabricant
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 dispositifs médicaux avec un nom similaire

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Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05511046001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.
Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05511054001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.
Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05511038001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.
Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05510970001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.
Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05510988001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.
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