FDAFDA · Food and drugs·Recall number Z-1512-2017
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Published March 29, 2017 · Recall initiated: February 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Devicor Medical Products Inc
- Distributor
- Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
- Lot
- F11621304D1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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