ICU Medical—Smallbore Trifuse Extension Sets: May Contain Incorrect Filter Assembly Configuration

July 22, 2020 | Strategic Insights for Health System


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In a July 1, 2020, Urgent Medical Device Recall letter submitted by an ECRI member hospital, ICU Medical states that the above administration sets may contain an incorrect filter assembly configuration of two 0.2 micron filters or two 1.2 micron filters instead of one 0.2 micron filter and one 1.2 micron filter. ICU Medical also states that this problem may lead to contamination, particulate embolism, or a delay in therapy. ICU Medical further states that it has received no reports of serious injury or death associated with this problem. The manufacturer has not confirmed the...

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