Fargo Guiding Catheter (2018-06-28)
- Starting date:
- June 28, 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-67162
Affected products
Fargo Guiding Catheter
Reason
A labelling error was observed for these devices (LOT #: from 00243032 to 00312502 inclusive). The catheter tube length appears correctly in "cm" (in prominent bold font) on the left side of the label; however, on the right side of the label, the catheter tube length incorrectly appears as "mm".
Affected products
Fargo Guiding Catheter
Lot or serial number
All lots.
Model or catalog number
FRGMIN4.2F120MP
FRGMIN4.2F135
Companies
- Manufacturer
-
Balt Extrusion
10 Rue Croix-Vigneron
Montmorency
95160
FRANCE