FLOVAC SUCTION/IRRIGATION CONTROL HANDLES (2016-06-29)

Starting date:

June 29, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-59470

• Reason
• Affected products

Affected products

A. FLOVAC SUCTION/IRRIGATION CONTROL HANDLES

Reason

The core suction irrigation handpieces are sold as sterile, single use devices. ConMed has identified certain core suction irrigation product with creases in the packaging seal which sometimes result in an open channel. These channels may compromise sterility of the product. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury.

Affected products