Recall Z-0159-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
MAQUET Inc.
Jostra HL-20 Heart Lung Machine - guiding pins
| Date | Nov 7, 2006 (initiated Oct 3, 2006) |
| Status | Terminated |
| Reason | The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck. |
| Root cause | Other |
| Action | An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt. |
| Quantity | 227 HL-20 base units with 545 single pumps |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943803 | JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM Janus Biomedical, Inc., Jan 30, 1996 |