Recall Z-0732-2016 ยท NWV Laparoscopic Accessories, Gynecologic
JosNoe Medical, Inc.
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
| Date | Jan 30, 2016 (initiated Dec 1, 2015) |
| Status | Terminated |
| Reason | Damage to package seals potentially compromising sterility. |
| Root cause | Packaging process control |
| Action | On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product. |
| Quantity | 1008 boxes |
| Distribution | Distributed US (nationwide) and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.