FDA-Device2023-08-09Class II
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Covidien, LLC
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.
Sold states
Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
Affected count
6902
Manufactured in
3062 Bunker Hill Ln, N/A, Santa Clara, CA, United States
Products
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2282-2023Don't want to check this manually?
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