Recall Z-2282-2023 ยท EOX Esophagoscope (Flexible Or Rigid)
Covidien, LLC
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
| Date | Aug 2, 2023 (initiated Jun 2, 2023) |
| Status | Open, Classified |
| Reason | 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 | Process control |
| Action | 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 pro |
| Quantity | 6902 |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181020 | Cytosponge Cell Collection Device Covidien, LLC, Aug 16, 2018 |