Z-2201-2015 Class II Terminated
FDA device recall Z-2201-2015 was initiated by Myoscience Inc on July 1, 2015 and is designated Class II. Reason for recall: 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 lab… The recall status is terminated (terminated September 8, 2015). Affected quantity: 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count..
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- July 1, 2015
- Termination Date
- September 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Code Information
Catalog numbers:STT0412-¿10 and STT0412-¿5; Lot numbers : 1504021-¿01 and 1505008.