Various Paragon Oxygenators (2017-06-07)

Starting date:

June 7, 2017

Posting date:

October 6, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-64764

• Reason
• Affected products

Affected products

A. PARAGON OXYGENATOR
B. PARAGON INFANT MICRONET INTEGRATED OXYGENATOR
C. PARAGON INFANT PMP OXYGENATOR
D. PARAGON NEONATAL PMP OXYGENATOR

Reason

Due to the coating used on the Paragon Oxygenators, the classification originally assigned to the oxygenators (class II), is to be amended to a class IV. Until the class IV application has been processed, manufacturer will voluntarily cease sale of the Paragon Oxygenators.
This does not affect products that have already been sold to customers

Affected products