Home / Recalls / Medical Devices
Myoscience Inc recalls iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are
Recalled July 29, 2015 · FDA recall Z-2201-2015 · Myoscience
Hazard
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. · FDA Class II
Units
12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
Sold at
US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Description
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.
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
Manufacturer(s)
Myoscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →