Recall Z-0103-04 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.
| Date | Nov 7, 2003 (initiated Oct 16, 2003) |
| Status | Terminated |
| Reason | The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion. |
| Root cause | Other |
| Action | Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility. |
| Quantity | 263 |
| Distribution | United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |