Unomedical recalls VariSoft infusion sets with model 1002830 due to connector damage causing missed insulin doses, risking diabetic ketoacidosis. Affected units have 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.
Unomedical is recalling VariSoft infusion sets with model number 1002830 because a manufacturing defect causes the connector to detach easily. This can lead to missed insulin doses during sleep, potentially causing high blood sugar and 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 elevated blood glucose and ketone levels, potentially resulting in diabetic ketoacidosis.
Diabetic patients using Unomedical VariSoft infusion sets with model 1002830 are most at risk. Those who have the specific serial numbers or GTINs listed in the recall are affected.
Check for model number 1002830 on the infusion set. Affected units have specific serial numbers: 5388368 (for GTIN 05705244018792) or 5388368 (for GTIN 05705244018785).
Look for model number 1002830 on the VariSoft infusion set.
The recalled model number is 1002830.
If the connector detaches, it can cause missed insulin doses, leading to high blood glucose and ketone levels, which may result in diabetic ketoacidosis.
Check for model number 1002830 and specific serial numbers: 5388368 (for GTIN 05705244018792) or 5388368 (for GTIN 05705244018785).
We’ve drafted a message you can send Unomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2024 — Unomedical Unomedical Hello, I own a Unomedical that is covered by recall Z-0234-2024 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.
