Recall Z-2106-2018 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
| Date | Mar 11, 2016 |
| Status | Terminated |
| Reason | There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE. |
| Root cause | Under Investigation by firm |
| Action | Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via ema |
| Quantity | 19 total kits |
| Distribution | The products were distributed to the following US states: AL, OR, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080592 | HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG, Sep 11, 2008 |