Reported Jul 13, 2016 · Terminated
Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection…
Covidien, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LLC · 540 Oakmead Pkwy · Sunnyvale, CA · 94085-4022
Is this the product you have?
- 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
- Lot codes and dates
- Item CodeCYTO-101-01
- Lot numbers
F2500566XF2500628XF2500202XF2500351X
- Amount recalled
- 620 total units (260 US; 360 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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