Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported November 29, 2023
VariSoft infusion set, Model Number 1002828
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Unomedical A/s recalled VariSoft infusion set, Model Number 1002828 - a critical-severity action.
VariSoft infusion set, Model Number 1002828 was recalled by Unomedical A/s in November 29, 2023. Reason: The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to…. Check the official notice for the remedy. Verify recall #Z-0233-2024 with the FDA Devices before acting.
The recall
Unomedical A/s issued this critical-severity FDA Devices recall-The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- November 29, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0233-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0233-2024) was formally reported on November 29, 2023, with the manufacturer initiating the action on October 11, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Unomedical A/s is listed as the recalling firm, operating out of LEJRE, N/A. Federal records list the affected scope as 1679 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1679 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0233-2024 |
| Date reported | November 29, 2023 |
| Date initiated | October 11, 2023 |
| Recalling firm | Unomedical A/s |
| Firm location | LEJRE, N/A |
| Affected scope | 1679 units |
| Distribution | US Nationwide distribution in the state of CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0233-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
VariSoft infusion set, Model Number 1002828. Recalled by Unomedical A/s. Units affected: 1679 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Critical. Recall number: Z-0233-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0233-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 29, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.