UNI-COT (2020-12-15)

Starting date:

December 15, 2020

Posting date:

December 24, 2020

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-74637

Last updated: 2020-12-24

• Reason
• Affected products

Affected Products 

UNI-COT

Reason

In rare instances, the device may split into two pieces during removal leaving a portion of the device on the patient's digit. If a portion of the device is in place, it will continue to constrict blood flow to the digit resulting in ischaemia. This split can occur when removal is attempted by making a partial snip at the edge of the device and then pulling the device from the affected digit, leaving a constricting band on the patient. Removal of a portion of the device may give user the false impression that the entire device was removed if not observed with care.

Affected products