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