Universal Electrosurgical Pad

Starting date:

October 28, 2016

Posting date:

November 25, 2016

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-61216

• Reason
• Affected products

Reason

This voluntary recall follows confirmation of a single user report from outside of Canada which resulted in 3M identifying an unintended material (process liner) in the product. The presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.

Affected products