Single Patient Use Lead Set (2019-09-03)

Starting date:

September 3, 2019

Posting date:

October 3, 2019

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-71131

Last updated: 2019-10-03

• 
  Reason
• 
  Affected products

Affected Products

Single Patient Use Lead Set

Reason

The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. As a result, the receptacle in the trunk cable for the 5-lead chest lead set may be partially blocked, preventing or impeding the connection of all leads necessary to obtain a 12-lead ECG measurement.

Affected products