Endotine Transbleph 3.5 recall: Labeling Error
Endotine Transbleph 3.5 (CFD-080-0167)
Why was Endotine Transbleph 3.5 recalled?
MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
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?
Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
- Product
- Endotine Transbleph 3.5 (CFD-080-0167)
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Quantity
- 29
- Distribution
- The product was distributed in the United States and Sweden
- Recall date
- August 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)