Health product recall

Thermablate Disposable Cartridge and Thermablate Treatment Control Unit Kit (2018-07-18)

Starting date:
July 18, 2018
Posting date:
August 31, 2018
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-67610

Affected products

A. Thermablate Disposable Cartridge
B. Thermablate Treatment Control Unit Kit

Reason

The Field Safety Notification (FSN) was issued to inform Thermablate users of updated contraindications and warnings to the Thermablate IFU in addition to providing the user with safety and effectiveness data. Idoman-med does not intend to recall product from the field as there are no defective products.

Affected products

A. Thermablate Disposable Cartridge

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

21004

Companies
Manufacturer

Idoman Teoranta

Killateeaun

Tourmakeady, COUNTY MAYO

M016099

IRELAND

B. Thermablate Treatment Control Unit Kit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

22101

Companies
Manufacturer

Idoman Teoranta

Killateeaun

Tourmakeady, COUNTY MAYO

M016099

IRELAND