NxStage System One - Cycler (Chronic Application) (2019-10-17)

Starting date:

October 17, 2019

Posting date:

November 1, 2019

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-71475

Last updated: 2019-11-01

• 
  Reason
• 
  Affected products

Affected Products

NxStage System One - Cycler (Chronic Application)

Reason

In some instances, ultra filtration removed during dialysis may be greater or less than the target ultra filtration volume, which in the worst case could result in hypovolemia/hypotension or hypervolemia/hypertension and potential serious injury requiring medical intervention or hospitalization.

Affected products