Adult flexible tracheostomy Tube Cuffless 6.5 mm I.D. (2018-04-20)
- Starting date:
- April 20, 2018
- Posting date:
- July 5, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67158
Affected products
Adult flexible tracheostomy Tube Cuffless 6.5 mm I.D.
Reason
Medtronic is issuing a voluntary field safety notice following receipt of customer reports of an incorrectly labeled product. One lot of this product has the incorrect item code (4CN65H) printed on the green bar label of the inner carton. The correct item code, 4UN65H, appears on all other levels of labelling for the device including outer carton labels and device tray label.
Affected products
Adult flexible tracheostomy Tube Cuffless 6.5 mm I.D.
Lot or serial number
16H0665JZX
Model or catalog number
4UN65H
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES