Reported Jul 31, 2013 · Terminated
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number:…
Myoscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Myoscience Inc · 1600 Seaport Blvd Suite 450 · Redwood City, CA · 94063-5563
Is this the product you have?
- Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device
- REF Catalog NumberSTA0311-10
- Product UsageThe Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue
- Lot codes and dates
- Serial Numbers
100100100101100103
- Serial Numbers
- Amount recalled
- 3 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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