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