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Health product recall

Hercules 360 and Hercules 3 Universal Stabilizer Arms (2015-01-26)

Starting date:
January 26, 2015
Posting date:
February 6, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43571

Recalled products

  1. Hercules 360 Universal Stabilizer Arm
  2. Hercules 3 Universal Stabilizer Arm

Reason

If the cable breaks, the stainless steel links on the arm can fall off. There is potential that these links may fall into the surgical site. If a component falls into a patient's body cavity, it is unlikely to cause patient injury. The event could, however, lead to a delay in the procedure as the surgeon retrieves the component.

Affected products

A. Hercules 360 Universal Stabilizer Arm

Lot or serial number

Not applicable

Model or catalog number
  • T401160
Companies
Manufacturer

Terumo Cardiovascular System Corporation

125 Blue Ball Road

Elkton

21921

Maryland

UNITED STATES



B. Hercules 3 Universal Stabilizer Arm

Lot or serial number

Not applicable

Model or catalog number
  • T401161
Companies
Manufacturer

Terumo Cardiovascular System Corporation

125 Blue Ball Road

Elkton

21921

Maryland

UNITED STATES