Recall Z-0233-2024— Unomedical A/S

Name: FDA recall Z-0233-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-11

Class I · Ongoing

Class I FDA medical device recall by Unomedical A/S, initiated 2023-10-11. It names one FDA 510(k) clearance: K162812. Product: VariSoft infusion set, Model Number 1002828. Reason: 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..

Recalling firm: Unomedical A/S
Classification: Class I
Status: Ongoing
Initiated: 2023-10-11
Firm location: LEJRE, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K162812 — 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 SetUnomedical A/S·cleared 2017-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VariSoft infusion set, Model Number 1002828

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.