Events

Recall of Device Recall ACCUCHEK FlexLink Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Insulin Delivery Systems Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58015
  • Event Risk Class
    Class 1
  • Event Number
    Z-1492-2011
  • Event Initiated Date
    2011-02-24
  • Event Date Posted
    2011-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98002
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Infusion Pump - Product Code FRN
  • Reason
    There is the potential to kink or bend the cannula when inserting the accu-chek flexlink plus infusion set. this can lead to under delivery and elevation of blood glucose levels.
  • Action
    Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.

Device

Device Recall ACCUCHEK FlexLink Plus
  • Model / Serial
    Part Number: 05511089001.  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 05511089001. || 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.

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