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Health product recall

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

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

Spectra Optia Apheresis System

Lot or serial number

All lots.

Model or catalog number
  • 61000
Companies
Manufacturer

Terumo BCT Inc.

10811 W. Collins Avenue

Lakewood

80215

Colorado

UNITED STATES