5008 Cordiax HD-PAED option (2018-06-26)

Starting date:

June 26, 2018

Posting date:

July 13, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67224

• 
  Reason
• 
  Affected products

Affected products

5008 Cordiax HD-PAED option

Reason

In the unlikely event of a leakage in the hydraulic system, balancing errors of up to 125 ml/h are possible. For patients < 17 kg body weight this could potentially lead to circulatory dysregulation with potential overhydration or underhydration and subsequent impact on cardiovascular stability.

Affected products