Unomedical recalls VariSoft infusion sets (Model 1002828) due to connector detachment risk causing missed insulin doses and potential diabetic ketoacidosis. Affected units include specific serial numbers and GTINs.
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.
Unomedical is recalling VariSoft infusion sets with model number 1002:2828 due to a manufacturing defect that makes the connector detach more easily. This can lead to missed insulin doses, causing high blood sugar and ketones, which may result in diabetic ketoacidosis.
The connector piece can become detached more easily than intended during use, especially when not detected during sleep. This leads to missed insulin doses, which can cause high blood sugar and ketones, potentially resulting in diabetic ketoacidosis.
Diabetic patients using Unomedical VariSoft infusion sets with model number 1002828 are most at risk. Affected units include specific serial numbers and GTINs listed in the recall.
Check for model number 1002828 on the infusion set. Affected units have specific serial numbers (5388367, 5388376) or GTIN 05705244018723 and 05705244018730.
Verify the model number on the infusion set; affected units have model number 1002828.
Reach out to Unomedical A/S for guidance on next steps if you have the affected model.
The recalled model number is 1002828.
Check for model number 1002828 and specific serial numbers (5388367, 5388376) or GTINs (05705244018723, 05705244018730).
Detachment can cause missed insulin doses, leading to high blood sugar and ketones, which may result in diabetic ketoacidosis.
We’ve drafted a message you can send Unomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0233-2024 — Unomedical Unomedical Hello, I own a Unomedical that is covered by recall Z-0233-2024 from Unomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
