CRYOcheck Factor II Deficient Plasma (2017-12-07)
- Starting date:
- December 7, 2017
- Posting date:
- January 8, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65546
Affected Products
CRYOcheck Factor II Deficient Plasma
Reason
Typographical error on the vial labels. Catalogue number (ref) and lot number (lot) symbols are switched. The labeling on the outer box and all other labeling accompanying the product is accurate. The reversed ref/lot symbols were noticed during in-house use of fdp02-10 lot d2-34 on Nov 29, 2017.
Affected products
CRYOcheck Factor II Deficient Plasma
Lot or serial number
D2-34
Model or catalog number
FDP02-10
Companies
- Manufacturer
-
Precision BioLogic Inc.
140 Eileen Stubbs Avenue
Dartmouth
B3B 0A9
Nova Scotia
CANADA