Health product recall

Mammotome Revolve Stereotactic Prob and Mammotome Revolve Ultrasound Probes (2018-06-27)

Starting date:
June 27, 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-67626

Affected products

A. Mammotome Revolve Stereotactic Prob
B. Mammotome Revolve Ultrasound Probes

Reason

A customer reported a MST1009 probe in an incorrect pre-printed box. Additionally, the recall was expanded to include a potential pre-printed box mismatch on product code MHUS08. The pre-printed box is the only defect. All variable labeling information is correct for the product code.

Affected products

A. Mammotome Revolve Stereotactic Prob

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MST1009

Companies
Manufacturer
DEVICOR MEDICAL PRODUCTS, INC.,
300 E-BUSINESS WAY, FIFTH FLOOR
CINCINNATI
45241
Ohio
UNITED STATES

B. Mammotome Revolve Ultrasound Probes

Lot or serial number

F11731374D
F11734447D
F11739454D
F11740401D
F11743449D
F11745471D
F11746457D
F11802402D
F11805468D

Model or catalog number

MHUS08

Companies
Manufacturer
DEVICOR MEDICAL PRODUCTS, INC.,
300 E-BUSINESS WAY, FIFTH FLOOR
CINCINNATI
45241
Ohio
UNITED STATES