Thermophore

Starting date:

November 3, 2016

Posting date:

November 18, 2016

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-61154

• Reason
• Affected products

Reason

The issue was that the product fails prematurely when misused. The failure is specifically in the area where the electric cord meets the strain relief switch. In cases where a user repeatedly bends and stresses the cord at a sharp tight angle, the cord may wear leading to a quick spark when the wire inside the cord fails. This then may lead to a visible spark, small amounts of smoke or small amounts of carbon residue when it fails. The failure does not have any likelihood of injuring the user. This failure mode has been seen in less than one-hundredth of one percent (.09%) of units in the field.

Affected products