Recall Z-1119-2020 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
LivaNova USA Inc.
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
| Date | Jan 28, 2019 |
| Status | Terminated |
| Reason | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd. |
| Root cause | Error in labeling |
| Action | On 01/28/2019, a Medical Device Correction letter was mailed to affected consignees. The letter asked customers to take the following actions: 1. Please check your inventory using the list of affected products delivered to your facility in Attachment 1; 2. Using the attached Customer Response Form (Attachment 2), please respond by email to USFSN@livanova.com to confirm that you have affected products in your facility. Your LivaNova reference person will contact you for the replacement of the product labels with labels bearing the correct manufacturing date. 3. Please ensure that this Medic |
| Quantity | 5 Datapads |
| Distribution | US: NJ and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jul 6, 2007 |