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FDAAugust 31, 2020device

30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

What to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286 — Recall Details · AllClear