Health product recall

BonD-MaX and BOND-III System (2018-09-13)

Starting date:
September 13, 2018
Posting date:
October 5, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67884

Affected products

A. BonD‑MaX System

B. BOND-III System

Reason

This Field Action Notice applies to the Zebra Power Supply Unit (PSU) for the Zebra printer models Zebra TLP3842 (affected PSU part number 808113-001 or P1028888-001) and Zebra GX430t (affected PSU part number 808101-001. These were supplied by Leica Biosystems as part of the bond slide labeler for use with bond-iii and bond-max instruments.

The affected models of Zebra printers, which serve as the external power source for these printers, have been identified as potentially containing an improperly mixed phosphorus compound that is used in the flame retardant resin in the DC power supply connectors. This deficiency in the phosphorus based connector resin, when combined with moisture and humidity over time, can potentially lead to overheating or a fire hazard.

Affected products

A. BonD‑MaX System

Lot or serial number

Not applicable

Model or catalog number

Not applicable

Companies
Manufacturer

Leica Biosystems Melbourne Pty. Ltd.

495 Blackburn Road

Mount Waverley, Victoria

3149

AUSTRALIA


B. BOND-III System

Lot or serial number

Not applicable

Model or catalog number

Not applicable

Companies
Manufacturer

Leica Biosystems Melbourne Pty. Ltd.

495 Blackburn Road

Mount Waverley, Victoria

3149

AUSTRALIA