BD has told hospitals that some of its Alaris pump infusion sets perform worse than the company previously disclosed, and the U.S. Food and Drug Administration has updated its Class I recall notice to reflect the revised data. Class I is the FDA's most serious recall category, used when there is a reasonable chance a product will cause serious health problems or death. The FDA's recall database lists 33,162,680 affected units.
The correction matters because hospitals made clinical decisions based on the earlier numbers. In its updated recall notice, the FDA said BD's continued testing "found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse." For a parent with a newborn in intensive care, or a family member receiving slow, precise IV medication, the question is no longer only whether a set was recalled. It is whether the performance figures that guided their care team were accurate, and what has changed now.
