Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Reported: March 29, 2017 Initiated: February 28, 2017 #Z-1512-2017
Product Description
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Reason for Recall
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.
Details
- Recalling Firm
- Devicor Medical Products Inc
- Units Affected
- 320
- Distribution
- Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance. Recalled by Devicor Medical Products Inc. Units affected: 320.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1512-2017.
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