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FDAJune 2, 2023device

Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

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

The hazard

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

What to do

FDA enforcement status: Ongoing

Brands named

covidien

UPCs

2088452176778910884521546257

Recall history

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

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Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM — Recall Details · AllClear