Devices

Device Recall ACCUCHEK FlexLink Plus

  • Model / Serial
    Part Number: 05511020001.  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 05511020001. AC FLEXLINK PLUS SET 8/70 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.
  • 1 Event

Manufacturer

Roche Insulin Delivery Systems Inc.
  • Manufacturer Address
    Roche Insulin Delivery Systems Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA

12 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.
7 more