Unomedical Infusion Set Recall Letter


Dear Valued Asante Customer,


The purpose of this letter is to advise you that Unomedical a/s is voluntarily recalling all
lots of the Asante comfort™ and Asante conset™ infusion sets used with the Asante
Snap™ Insulin Pump System. As the distributor of Unomedical’s infusion sets, Asante
Solutions is assisting with the recall.
Serious injury or death could occur due to the failure of this product. We have received
one report of a high blood glucose level accompanied by high ketones and vomiting that
could have resulted in serious, permanent injury if the user had not been able to quickly
self-administer an insulin dose.


Reason for the Voluntary Recall:

Unomedical a/s is recalling all infusion sets because in rare instances the infusion
tubing can disconnect from the connector, resulting in leakage of insulin from the
infusion set. If the detachment occurs, delivery of insulin will be less than intended. Our
investigation has shown that detachment can occur in a small percentage of sets
because of problems with the adhesive used to secure the tubing into the connector.
We have received 15 complaints associated with detachment of the infusion set tubing
from the tubing connector. In 4 cases, the patients reported elevated blood glucose
levels and one patient also experienced a rise in ketone level with vomiting. To our
knowledge, none of the reported cases has required medical attention from a health
care professional.


Risk to Health:

Tubing detachment can lead to under-delivery of insulin, which can cause
hyperglycemia; in extreme cases, hyperglycemia may cause loss of consciousness or
death. Our investigation has found that tubing detachment, if not detected for an
extended period of time can lead to hyperglycemia.


How to Identify the Recalled Product:

You may have received Asante Comfort and/or Asante Conset infusion sets as a 5-
pack, in single configuration, or as part of a Combination Kit, as shown below:

You likely received a large box that includes the pump bodies and the infusion sets (a
combo kit shown in Figure 3 above). Please remove the Asante comfort or Asante
conset infusion set carton and follow the instructions below (do not return the pump
bodies). Infusion sets in any of these three configurations are included in the recall.



NOTE: The Asante Snap controller and pump bodies are NOT affected by this recall
and can continue to be used. They do NOT need to be returned.


A complete list of product that is being recalled is contained in Table 1 below.



Actions to be taken by the Customer:




READY

SNAP

GO

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More life time.