CanadaThe HydroMARK™ Breast Biopsy Site Marker (model/catalogue 4010-02-15-T3, lot F12607207D) is affected; boxes labeled 4010-02-15-T3 may contain individual packages labeled 4010-02-15-T4. The device was recalled due to incorrect inner package labeling, and users should immediately remove from use any devices labeled 4010-02-15-T4 from lot F12607207D and contact the manufacturer for additional information.
What's being recalled
Companies: Devicor Medical Products, Inc., 300 E-Business Way, Cincinnati, Ohio, United States, 45241.
How to identify it
Affected products: HydroMARK™ Breast Biopsy Site Marker; Lot or serial number: F12607207D; Model or catalogue number: 4010-02-15-T3
The hazard
Devicor Medical Products, Inc. is initiating a voluntary medical device recall for certain HydroMARK™ Breast Biopsy site markers due to incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. Users should immediately remove from use any devices labeled as 4010-02-15-T4 from lot F12607207D.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)