Health product recall

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