Z-0232-2024Class I

VariSoft infusion set, Model Number 1002827

Name: Z-0232-2024 VariSoft infusion set, Model Number 1002827
Creator: Unomedical A/S
Published: 2023-10-11
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2023-10-11 / Open, Classified / root cause: manufacturing process

FDA source

Unomedical A/S began a recall of VariSoft infusion set, Model Number 1002827 on 2023-10-11. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0232-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-10-11
Posted: 2023-11-21
Recalling firm: Unomedical A/S
Product: VariSoft infusion set, Model Number 1002827
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: 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: 8028 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: GTIN 05705244018709, Serial Numbers: 5388357, 5388362, 5388372, 5388366; GTIN 05705244018693, Serial Numbers: 5388357, 5388362, 5388372, 5388366

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0232-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20
Z-0233-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20
Z-0234-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

Product code FPA

K162812Class IIUnomedical 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)