Devices

Device Recall AccuChek

  • Model / Serial
    Lots 31097UF, 3C135UF, 3D001UF, 3E008UF, 3E065UF, 3G012UF, 3G107UF, 3G116UF, 3H040UF, 3H051UF, 3J018UF, 3K035UF, 3K101UF, 3L098UF, 3L122UF, 4A127UF, 4D030UF, 4D032UF, 4D161UF, 4D180UF, 4F020UF, 4F083UF, 4G184UF, 4H101IF, 4K133UF and 4L096UF.
  • 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
    Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001.
  • Manufacturer
    Disetronic Medical Systems, Inc.
  • 1 Event

Manufacturer

Disetronic Medical Systems, Inc.
  • Manufacturer Address
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

73 devices with a similar name

Learn more about the data here

Device Recall ACCUCHEK FlexLink Plus
  • Model / Serial
    Part Number: 05511046001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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
  • Model / Serial
    Part Number: 05511054001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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
  • Model / Serial
    Part Number: 05511038001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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
  • Model / Serial
    Part Number: 05510970001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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
  • Model / Serial
    Part Number: 05510988001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    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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