Recall Z-1394-2011 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
| Date | Feb 22, 2011 (initiated Sep 28, 2010) |
| Status | Terminated |
| Reason | A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function. |
| Root cause | Component change control |
| Action | Maquet hand delivered a letter to the consignee on 10/4/2010. |
| Quantity | 4 units |
| Distribution | One hospital in New York City |
| 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 |