Recall Z-2123-2016 ยท EOX Esophagoscope (Flexible Or Rigid)
Covidien, LLC
Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
| Date | Jun 6, 2016 |
| Status | Terminated |
| Reason | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus. |
| Root cause | Process control |
| Action | The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance MITGFCA@Covidien.com or fax to |
| Quantity | 620 total units (260 US; 360 OUS) |
| Distribution | Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152794 | Cytosponge Cell Collection Device Covidien, LLC, Apr 12, 2016 |