ICU Medical recalls 14" Bifuse Transfer Sets (REF: 14237-28) due to missing blood filter. Use as blood transfusion set without filter risks infection. Affected units sold in specific lots.
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
ICU Medical is recalling 14-inch Bifuse Transfer Sets (REF: 14237-28) because they lack a blood filter. Using these sets for blood transfusions without realizing the filter is missing could lead to infection risks.
The device was redesigned from a blood set with a filter to a transfer set without a filter. Users might not realize the filter is missing and use it for blood transfusions, increasing infection risk.
Healthcare professionals using these sets for blood transfusions may be affected. Patients receiving transfusions with this set without a filter are at risk of infection.
Check for the model name 'Bifuse Transfer Set', size 14" (36 cm), and reference number 14237-28. Affected units were sold in specific lots: 85-540-SJ, 86-189-SL, 86-911-SJ.
Look for the model name 'Bifuse Transfer Set', size 14" (36 cm), and reference number 14237-28 on the device.
The device was redesigned from a blood set with a filter to a transfer set without a filter. Users might not realize the filter is missing and use it for blood transfusions.
Using this set for blood transfusions without a filter could increase infection risk.
Check for the model name 'Bifuse Transfer Set', size 14" (36 cm), and reference number 14237-28. Affected units were sold in specific lots: 85-540-SJ, 86-189-SL, 86-911-SJ.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0069-2019 from ICU Medical. 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.
