Recall of Device Recall ACCU Chek Tender Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Unomedical As.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Tubing detachment.
  • Action
    ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing. You can continue to use your infusion sets by following the advice below. 1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose. 2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring. 3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure. If you discover the tubing is detached: 1. Do not attempt to reattach the tubing. Replace the infusion set immediately. 2. Treat any high blood sugar based on guidelines provided by your healthcare professional. 3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set. The letter included a reply card to be returned.


  • Model / Serial
    5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Product Description
    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer


  • Manufacturer Address
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Manufacturer Parent Company (2017)
  • Source