Color Cuff- Sterile Disposable Tourniquet Cuff (2019-11-04)

Starting date:

November 4, 2019

Posting date:

January 6, 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-71977

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

Color Cuff- Sterile Disposable Tourniquet Cuff

Reason

There is a potential for the cuff to leak air leading to a loss of vascular occlusion. The internal complaint database, trackwise, was reviewed for open and closed complaints related to leaking between July 1 2019 and October 11 2019. The complaint events were reported to have occurred during preparation for procedures and during surgical procedures.

Affected products