Device product
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.
Z-2123-2016
Product summary
- Firm
- Covidien, LLC
- Event
- Event 74300
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 total units (260 US; 360 OUS)
- Official record key
device-enforcement:Z-2123-2016
Official wording
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.
Code information: Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
Distribution pattern: Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
Derived failure modes
-
Unknown
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.