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U.S. Department of Health and Human Services

Class 1 Device Recall VariSoft infusion set

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  Class 1 Device Recall VariSoft infusion set see related information
Date Initiated by Firm October 11, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0233-2024
Recall Event ID 93269
510(K)Number K162812  
Product Classification Set, administration, intravascular - Product Code FPA
Product VariSoft infusion set, Model Number 1002828
Code Information GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
Recalling Firm/
Unomedical A/S
Aaholmvej 1 - 3
LEJRE Denmark
For Additional Information Contact Mr. Henrik Gyllun
45 48 16 7000
Manufacturer Reason
for Recall
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.
FDA Determined
Cause 2
Process change control
Action Unomedical a/s issued an Urgent Field Safety Notice to its sole consignee on 10/11/2023 via email. The notice explained the issue, potential risk to patient, and requested the distributor to quarantine all affected product pending return and to notify their customers.
Quantity in Commerce 1679 units
Distribution US Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = UNOMEDICAL A/S