# FDA recall Z-0232-2024

> **Unomedical A/S** · Class I · device recall initiated 2023-10-11.

## Product

VariSoft infusion set, Model Number 1002827

## 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.

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-0232-2024
- **Recalling firm:** Unomedical A/S
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** LEJRE, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2024

## Citation

> AI Analytics. FDA recall Z-0232-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0232-2024. Source: US FDA. Licensed CC0.

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