Health product recall

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