The Recall Desk

FDA (Devices) recall action 87703

ICU Medical, Inc. recalled 26 products on 2021-05-19

The FDA (Devices) publishes a recall like this one as 26 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 26 pages.

Products
26
Announced
2021-05-19
Critical
0
Units
—

Why these products were recalled

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

26–26 of 26

  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Admin Sets Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of REF 011-CH3967 Admin Sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: 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).
    Category
    Distribution
    39 states