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Health product recall

InSituSeal Hemostatic Gauze (2015-04-10)

Starting date:
April 10, 2015
Posting date:
May 1, 2015
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-53221

Recalled Products

A. InSituSeal Hemostatic Gauze

Reason

Recall initiated due to importation into Canada of unlicensed class II medical device, not in accordance with section 26 of MPR.

Affected products

A. InSituSeal Hemostatic Gauze

Lot or serial number

201011002
201104001
201104002
201208002
201210006

Model or catalog number

3005X05-S

Companies
Manufacturer
InSitu Technologies Inc.
539 Phalen Blvd
St. Paul
55130
Minnesota
UNITED STATES