HydroMARK Breast Biopsy Site Marker (2019-02-04)
- Starting date:
- February 4, 2019
- Posting date:
- March 1, 2019
- 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-69196
Affected Products
HydroMARK Breast Biopsy Site Marker
Reason
A product defect occurs when no marker plug is contained in the delivery system. Therefore, the marker is not deployed into the biopsy site as intended.
Affected products
HydroMARK Breast Biopsy Site Marker
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4010-02-15-T4
Companies
- Manufacturer
-
DEVICOR MEDICAL PRODUCTS, INC.,
300 E-BUSINESS WAY, FIFTH FLOOR
CINCINNATI
45241
Ohio
UNITED STATES