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Health product recall

STERIZONE VP4 sterilizer (2015-11-06)

Starting date:
November 6, 2015
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-56176

Affected Products

STERIZONE VP4 sterilizer

Reason

The manufacturer discovered that the component of the sterilizer (suction tube, FM-213-061, used to removed H2O2 sterilant from a contained bottle) was not in conformance with their engineering specification.

Affected products

STERIZONE VP4 sterilizer

Lot or serial number

S/N 1251213001

Model or catalog number

41100

Companies
Manufacturer
TSO3 INC.
2505 DALTON AVE.
SAINTE FOY
G1P 3S5
Quebec
CANADA