Recall Z-0292-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
| Date | Jan 9, 2007 (initiated Oct 6, 2005) |
| Status | Terminated |
| Reason | Six inch roller pumps were mislabeled as 4 inch roller pumps. |
| Root cause | Other |
| Action | The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06. |
| Quantity | 2 |
| Distribution | Worldwide-Michigan and Singapore. |
| 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 |