Lower riskMedical device recall · FDA · Published August 20, 2018
ICU Medical 14" Bifuse Transfer Set Recall: No Blood Filter Included
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.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
“ICU Medical 14" Bifuse Transfer Set Recall: No Blood Filter Included.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70014-icu-medical-14-bifuse-transfer-set-recall-no-blood-filter. Based on FDA recall #Z-0069-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2019%22&limit=1).
The FDA announced on 2018-08-20 that ICU Medical, Inc. is recalling its ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer due to a design change removing the blood filter. The agency said customers may unknowingly use the transfer set for blood transfusions without realizing it lacks a filter.
How to tell if you have it
Brand: ICU Medical
Product: ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer
REF: 14237-28
Lots: 85-540-SJ, 86-189-SL, 86-911-SJ
Units: 2361
The hazard
The recall addresses a design change that converted the device from a blood set with a filter to a transfer set without one. According to the FDA, customers may not be aware of this change and could use the product as a blood transfusion set without realizing a blood filter is not included.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since 2017-06-15. Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (2026-08-20), ICU Medical Hotline Fluid Warming Set Recall (2026-06-24), and 60004087 (2026-06-10). Other recent recalls of similar products include GVS TM SQ40S Blood Transfusion Filter Recall (2025-11-03) and B Braun Medical Blood Set Recall (2025-10-29).
How to tell if you have this one
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.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model name 'Bifuse Transfer Set', size 14" (36 cm), and reference number 14237-28 on the device.
Where it went and when
Where it was distributed
Distributed in 13 states.
Listed by the agency
Not listed
FDA distribution: “U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Georgia, Illinois, Michigan, Mississippi, New York, North Carolina, Pennsylvania, Utah, Washington, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0069-2019 (August 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0069-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.