Recall Z-1389-2020 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
LivaNova USA Inc.
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | Perfusion tubing pack was packaged with the incorrect cuvette. |
| Root cause | Employee error |
| Action | On 07/03/2019, the firm contact it customers in person and on 07/08/2019 sent a "MEDICAL DEVICE CORRECTION" Letter informing them of the incorrect cuvette was assembled into Perfusion Pack 046008200 (Lot Number 1912100141) and instructed the customers to: 1. Please check their inventory for PTS pack 046008200, with lot number 1912100141 delivered to their facility; 2. Using the attached Customer Response Form (Attachment 1), please respond by email to USFSN@livanova.com to confirm that they have affected products in their facility; 3. All PTS pack 046008200 with lot number 1912100141 should no |
| Quantity | 27 packs |
| Distribution | US Nationwide distribution in the state of IL. |
| 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 |