Myoscience brand iovera Smart Tip recall: Labeling Error
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The…
Why was Myoscience brand iovera Smart Tip recalled?
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
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?
Serial Numbers: 100100, 100101, 100103
- Product
- Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The…
- Recalling firm
- Myoscience Inc
- Quantity
- 3 units
- Distribution
- US distribution including CA and ID.
- Recall date
- July 31, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)