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Health product recall

Excelsior 10/18 and GDC-Ultrasoft Labelling Systems (2013-11-05)

Starting date:
November 15, 2013
Posting date:
November 29, 2013
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-36933

Recalled Products

A. Excelsior 10/18

B. GDC-Ultrasoft

Reason

Stryker has become aware of an issue with the global labeling software (GLS) system in Cork where the incorrect expiration date was assigned to printed production labels. Products were labeled with "Use by" dates that exceeded the actual product shelf life.

Affected products

A. Excelsior 10/18

Lot or serial number

17020618

17020619

Model or catalog number

M0031441900

Companies
Manufacturer

Stryker Neurovascular

47900 Bayside Parkway

Fremont

94538

California

UNITED STATES



B.     GDC-Ultrasoft

Lot or serial number

17008494

Model or catalog number

343203