Recall Z-0158-2007 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
MAQUET Inc.
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
| Date | Nov 7, 2006 (initiated Sep 1, 2006) |
| Status | Terminated |
| Reason | The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill. |
| Root cause | Other |
| Action | The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt. |
| Quantity | 132 or less in US. Firm officials stated that 66 base units in US 8/1/05 to 8/14/06 - each units comes with 2 hand crank |
| 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 |