VariSoft infusion set, Model Number 1002827

FDA device recall Z-0232-2024 · posted 2023-11-21 · Open, Classified

Recall details

Recalling firm: Unomedical A/S
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.
Action taken: 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.
Root cause: Process change control
Status: Open, Classified
Product code: FPA
Quantity affected: 8028 units
Distribution: US Nationwide distribution in the state of CA.
Date initiated: 2023-10-11
Date posted: 2023-11-21
Location: OSTED LEJRE, Denmark

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (K162812)	Unomedical A/S	2017-11-01