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