HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Quick Facts at a Glance
- Recall Date
- April 24, 2026
- Hazard Level
- HIGH
- Brand
- Devicor Medical Products
- Geographic Scope
- 1 states
Hazard Information
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Devicor Medical Products Inc or your healthcare provider for instructions. Notification method: Letter
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Full Description
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3. Reason: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.. Classification: Class II. Quantity: 1910 units. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
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