—#201597

Product

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

FDA product code: EOX — Esophagoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K181020
Affected lot / code info: 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.

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.

Root cause (FDA determination)

Process control

Action the firm took

On 6/2/23, Medtronic sent recall notices to customers who were informed of the following: 1) If product was purchased directly from Medtronic, return affected product to Medtronic. 2) If product was purchased from a distributor, return affected product to the distributor. 3) The recall notice should be passed on to all who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 4) Complete and return the Customer Confirmation Form to rs.gmbfcamitg@medtronic.com Adverse reactions or quality problems experienced with this product can be reported to Technical Support at dl.gi-usdl-ustecchsupport@medtronic.com or call 1-800-448-3644 option 3.

Recalling firm

Firm: Covidien, LLC
Address: 3062 Bunker Hill Ln, Santa Clara, California 95054-1105

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.

Timeline

Recall initiated: 2023-06-02
Posted by FDA: 2023-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.