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FDAMarch 16, 2021device

REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

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

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

UPCs

10840619073678

Recall history

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

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REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications. — Recall Details · AllClear