Device product
iovera 155 Smart Tip; Catalog numbers:STT0412-10 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 Usage: Cyrogenic 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
Z-2201-2015
Product summary
- Firm
- Myoscience Inc
- Event
- Event 71650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
- Official record key
device-enforcement:Z-2201-2015
Official wording
Reason: 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.
Code information: Catalog numbers:STT0412-¿10 and STT0412-¿5; Lot numbers : 1504021-¿01 and 1505008.
Distribution pattern: US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled