Covidien Cytosponge Cell Collection Device recall
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Why was Covidien Cytosponge Cell Collection Device 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI/Lot: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, 22F0950JZX, 22G0007JZX, 22G0008JZX, 22G0723JZX, 22G0724JZX, 22H0017JZX, 22H0018JZX, 22H0019JZX, 22H0820JZX, 22H0821JZX, 22H1158JZX, 22H1159JZX, 22H1161JZX, 22J0162JZX, 22J0163JZX, 22J0164JZX, 22J1030JZX, 22K0966JZX, 22K0967JZX, 23B0301JZX, 23B0303JZX; CYTO-KIT-USM/10884521546257/22G0635JZX, 22E1624JZX, 22E1625JZX.
- Product
- Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
- Recalling firm
- Covidien, LLC
- Quantity
- 6902
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)