HydroMARK Breast Biopsy Marker (2018-09-25)

Starting date:

September 25, 2018

Posting date:

October 19, 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-67950

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  Reason
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  Affected products

Affected products

HydroMARK Breast Biopsy Marker

Reason

To inform customers of incorrect labeling on the primary pouch and secondary carton packaging of several lots of the HydroMARK Breast Biopsy Marker, product code 4010-02-18-t3. Label indicates that the product is for use with a 13 ga x 9 cm Coaxial Introducer Needle. Label should have read for use with a 16 ga x 9 cm Coaxial Introducer Needle.

Affected products