Recall Z-2795-2017 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
| Date | Jun 29, 2017 |
| Status | Terminated |
| Reason | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers. |
| Root cause | Other |
| Action | The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017. The actions to be taken by the customer: 1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs. 2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure. 3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack. 4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the L |
| Quantity | 4 units |
| Distribution | Nationwide |
| 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 |