The Recall Desk

FDA (Devices) recall action 74300

Covidien, LLC recalled 2 products on 2016-07-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-07-13
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports

    Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.

    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.
    Category
    Distribution
    7 states
  • SevereFDA (Devices)··2016-07-13

    Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports

    Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.

    Product
    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophag
    Category
    Distribution
    7 states