Health product recall

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