upsylon Y mesh kit (2021-04-15)

Starting date:
April 15, 2021
Posting date:
April 29, 2021
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-75497

Last updated:

Affected Products 

upsylon Y mesh kit

Reason

BSC has detected through internal testing the potential for pinholes (sterile barrier breach) on the edge of the pouch of the Colpassist Vaginal Positioning Device which are not likely to be detected by the user and may potentially render the device non-sterile.

Affected products

upsylon Y mesh kit

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

M0068318220

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