Atricure Inc recall: Labeling Error
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when…
Why was Atricure Inc recalled?
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
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?
Model Number(s): MAX1 A000163, Lot Number 41865
- Product
- Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when…
- Recalling firm
- Atricure Inc
- Quantity
- 5 devices
- Distribution
- Nationwide Distribution including the states of MD, PA and TX.
- Recall date
- March 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)