Mammotome Revolve Dual Vacuum Assist Biopsy System The recall: Labeling Error
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging…
Why was Mammotome Revolve Dual Vacuum Assist Biopsy System The 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
F11621304D1
- Product
- Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging…
- Recalling firm
- Devicor Medical Products Inc
- Quantity
- 320
- Distribution
- Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)