Reported Jul 29, 2015 · Terminated
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are…
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 · 46400 Fremont Blvd · Fremont, CA · 94538-6469
Is this the product you have?
- iovera 155 Smart Tip
- Catalog numbersSTT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes
- Product UsageCyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissue
- Lot codes and dates
- Catalog numbersSTT0412-¿10 and STT0412-¿5
- Lot numbers1504021-¿01 and 1505008
- Amount recalled
- 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
Where it was sold
Why it was recalled
The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
This product could cause temporary or reversible health problems — stop using it.
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