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:
2021-04-29

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  Reason
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  Affected products

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