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