Health product recall

uosylon y mesh kit (2021-04-15)

Starting date:
April 15, 2021
Posting date:
May 6, 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-75527



Last updated:
2021-05-06

Affected Products 

uosylon y mesh kit

Reason

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

uosylon 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