Spectra Optia Apheresis System (2018-04-03)

Starting date:

April 3, 2018

Posting date:

April 24, 2018

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-66544

• 
  Reason
• 
  Affected products

Affected products

Spectra Optia Apheresis System

Reason

If a blood warmer is added after a procedure is initiated, the Spectra Optia will not prompt the user to prime the blood warmer.  If the blood warmer tubing is not primed, air will be infused into the patient/donor.  No customer reports have been received of air being returned to a patient due to an unprimed blood warmer.

Affected products