Health product recall

Guider SoftTip XF (2017-12-13)

Starting date:
December 13, 2017
Posting date:
January 8, 2018
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-65540

Affected Products

GUIDER SOFTIP XF

Reason

Certain lots of Guider 7F and 8F product may be at risk of degrading within their shelf-life period. The root cause of the issue is exposure of components to UV light while in storage between 2014 and October 2017.

Affected products

GUIDER SOFTIP XF

Lot or serial number

Various serial number contact manufacturer.

Model or catalog number

H965100430
H965100440
H965100470
H965100510
H965100520
M003101430
M003101440
M003101520

Companies
Manufacturer
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES