Recall Z-0664-2018 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
LivaNova USA
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
| Date | Dec 19, 2017 |
| Status | Terminated |
| Reason | The product is labeled with the incorrect expiration date. |
| Root cause | Process control |
| Action | The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017. |
| Quantity | 16 units (6 from lot 1717800062 and 10 units from lot 1720800071 |
| Distribution | Distribution was made to one consignee in LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981613 | COBE SMARXT TUBING AND CONNECTORS Cobe Cardiovascular, Inc., Oct 26, 1998 |