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BARD ENCOR PROBES (2016-04-18)
- Starting date:
- April 18, 2016
- Posting date:
- April 29, 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-58152
Affected Products
BARD ENCOR PROBES
Reason
Specific product codes and lot numbers of EnCor Biopsy Probes (vertical configuration) may have an incorrect sample trap assembly (lateral configuration). A portion of the affected lots contain units with incorrect sample trap assemblies affixed to the probe inside the product tray. The labeling on the outer product carton and inside packaging tray is correct. The incorrect sample trap assembly contains a shorter vacuum tubing and no clear tray cover.
Affected products
BARD ENCOR PROBES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ECP0110GV
ECP0112GV
ECP017GV
Companies
- Manufacturer
-
SENORX INC
1625 WEST 3RD STREET
TEMPE
85281
Arizona
UNITED STATES