Unomedical recalls Autosoft 90 insulin pumps with specific model numbers due to incorrect insulin fill value instructions potentially causing under-dosing. Affected users should check their pump model and lot numbers.
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Unomedical is recalling certain Autosoft 90 insulin pumps because the user manual incorrectly states the insulin fill value for two cannula sizes. This could lead to fewer insulin units being delivered than intended, risking under-treatment of diabetes. Affected users should stop using the pump until they can confirm their model and lot numbers.
The user manual incorrectly states the insulin fill value for two cannula sizes. This can cause the pump to deliver fewer insulin units than intended, potentially leading to under-treatment of diabetes. However, the risk is not immediate or severe under normal use conditions.
People using Unomedical Autosoft 90 insulin pumps with the listed model numbers and lot numbers are affected. Those with diabetes who rely on these pumps for insulin delivery are most at risk.
Check your Autosoft 90 pump's model number (1000282, 1002817-1002824) and lot number. The pump is used with Tandem Insulin Subcutaneous Infusion Pumps and has a UDI-DI code of 05705244018129.
Identify your Autosoft 90 pump's model number (1000282, 1002817-1002824) and lot number from the product description.
The user manual incorrectly states the insulin fill value for two cannula sizes, which can result in fewer insulin units being delivered than intended.
Check your pump's model number and lot number to see if it's affected. If it is, stop using it until you can confirm the model and lot numbers.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Unomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1810-2022 — Unomedical Unomedical Hello, I own a Unomedical that is covered by recall Z-1810-2022 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.
