This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
SENOMARK ULTRACOR BREAST TISSUE MARKERS
- Starting date:
- October 14, 2016
- Posting date:
- November 3, 2016
- 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-60788
Affected Products
Reason
Bard has confirmed that specific product code / lot number combinations of SenoMark UltraCor™ MRI Breast Tissue Marker may have incorrect instructions for use (IFU) containing a table in the description section misidentifying the wireform shape and material. The label on the outside of the box contains the correct information.
Affected products
SENOMARK ULTRACOR BREAST TISSUE MARKERS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- SMUCMRI14GSS
- SMUCMRI14GT
Companies
- Manufacturer
-
Senorx Inc
1625 West 3rd Street
Tempe
85281
Arizona
UNITED STATES