Recall Z-2201-2015 ยท GXH Device, Surgical, Cryogenic
Myoscience Inc
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
| Date | Jul 22, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Incorrect or no expiration date |
| Action | Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500. |
| Quantity | 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count. |
| Distribution | US Nationwide Distribution in the states of TX, NY, MD, CO and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142866 | Myoscience iovera system Myoscience, Inc., Jan 21, 2015 |