Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ICU Medical 14" (36 cm) Appx 3.6 ml Recalled by ICU Medical, Inc. Due to Design change implemented changing the device from a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected Products
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Quantity: 2361 Units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 13 states: AL, CA, FL, GA, IL, MI, MS, NY, NC, PA, UT, WA, WI
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report