EN MENTOR Round High Profile Single Use Saline Breast recall: Labeling Error
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product…
Why was EN MENTOR Round High Profile Single Use Saline Breast recalled?
The device labeling is stamped with 330cc and the device is actually 380cc device.
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?
Part Number (PN) 351-3380SZ Lot Number 6830722
- Product
- EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product…
- Recalling firm
- Mentor Texas, LP.
- Quantity
- 34 units
- Distribution
- U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)