Reported Jul 13, 2016 · Terminated
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.…
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 Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative
- Item code CYTO-KIT-R GastroenterologyCytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies
- Lot codes and dates
- Item CodeCYTO-KIT-R
- Lot numbers
34411209153441102015
- 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.
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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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