Health product recall

Elements Obturation Unit (2017-12-28)

Starting date:
December 28, 2017
Posting date:
January 29, 2018
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-65812

Affected products

Elements Obturation Unit

Reason

A recent increase in complaints related to overheating Elements Obturation Units (EOU). Buchannan pluggers turn hot when used with the Elements Obturation Unit.

Affected products

Elements Obturation Unit

Lot or serial number

All serial numbers.

Model or catalog number

973-0322

Companies
Manufacturer

SybronEndo

1717 W Collins Ave

Orange

92867

California

UNITED STATES