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MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM (2016-05-26)
- Starting date:
- May 26, 2016
- Posting date:
- June 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59014
Affected products
A. MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM
Reason
It has come to the attention of Devicor Medical Products, Inc. That a MST1009 probe for the Mammotome revolve biopsy device in a stereotactic application may have been mislabeled. It is a 10 gauge device with a 9 cm needle. In lot number F11537107D1, a MST1009 was in a MST0815 package for a single unit. This single unit was identified by a customer and returned.
Affected products
A. MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM
Lot or serial number
- F11536423D1
- F11537107D1
- F11537109D1
Model or catalog number
- MST0815
- MST1009
Companies
- Manufacturer
-
DEVICOR MEDICAL PRODUCTS, INC.,
300 E-BUSINESS WAY, FIFTH FLOOR
CINCINNATI
45241
Ohio
UNITED STATES