Unomedical recalls VariSoft infusion sets with model 1002827 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 1002827 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 detach more easily than intended due to a manufacturing defect. If the detachment occurs during sleep without detection, it may cause missed insulin doses, leading to high blood glucose and ketones (nocturnal hyperglycemia), which can result in diabetic ketoacidosis.
Diabetic patients using Unomedical VariSoft infusion sets with model 1002827 are most at risk. Those with specific serial numbers or GTINs listed in the recall are affected.
Check for model number 1002827 on the infusion set. Affected units have specific serial numbers: 5388357, 5388362, 5388372, 5388366. Also look for GTIN 05705244018709 or 05705244018693.
Verify the model number on your VariSoft infusion set; affected units have model 1002827.
Reach out to Unomedical directly for guidance on next steps and potential remedies.
The affected model number is 1002827.
If the connector detaches and is not detected, it can cause missed insulin doses, leading to high blood glucose and ketones (nocturnal hyperglycemia), which may result in diabetic ketoacidosis.
The recall does not require immediate stop use; however, affected units should be checked and contacted for guidance.
We’ve drafted a message you can send Unomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0232-2024 — Unomedical Unomedical Hello, I own a Unomedical that is covered by recall Z-0232-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
