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).

Recall Insight

This FDA Devices action (record #Z-0069-2019) was formally reported on October 10, 2018, with the manufacturer initiating the action on August 20, 2018. It is classified under Moderate severity (Class II), with a current status of Completed. Icu Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records list the affected scope as 2361 Units.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.