Reported Aug 9, 2023 · Ongoing
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF:…
Covidien, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LLC · 3062 Bunker Hill Ln · Santa Clara, CA · 95054-1105
Is this the product you have?
- Covidien Cytosponge Cell Collection Device
- REFCYTO-201; and Covidien Cytosponge Cell Collection Kit
- REFCYTO-KIT-USM
- Lot codes and dates
- REF/UDI-DI/Lot
CYTO-201/20884521767789/22E1619JZX22F0680JZX22F0950JZX22G0007JZX22G0008JZX22G0723JZX22G0724JZX22H0017JZX22H0018JZX22H0019JZX22H0820JZX22H0821JZX22H1158JZX22H1159JZX22H1161JZX22J0162JZX22J0163JZX22J0164JZX22J1030JZX22K0966JZX22K0967JZX23B0301JZX23B0303JZXCYTO-KIT-USM/10884521546257/22G0635JZX22E1624JZX22E1625JZX
- REF/UDI-DI/Lot
- Amount recalled
- 6902
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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