Paragon Oxygenator (2018-06-13)

Starting date:
June 13, 2018
Posting date:
June 22, 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-67094

Affected products

Paragon Oxygenator

Reason

During our quality checks, it was highlighted that the wrong expiry date had been allocated to one of the components used during the manufacture of oxygenators.  This resulted in products being given 2 or 3 months extra shelf life on top of the validated 2 years.

Affected products

Paragon Oxygenator

Lot or serial number
  • 012550
  • 012551
  • 012552
Model or catalog number

XCMOP*

Companies
Manufacturer
Chalice Medical Limited
Unit 1-2 Manton Wood Enterprise, Park, Drayton Court, Worksop
Nottinghamshire
S80 2RS
UNITED KINGDOM