Recall Z-2401-2010 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Maquet Inc.
Maquet HLM Tubing Pack; Bioline Coating
| Date | Sep 12, 2010 (initiated Jul 13, 2010) |
| Status | Terminated |
| Reason | The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged. |
| Root cause | Process control |
| Action | Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account. |
| Quantity | 5 units |
| Distribution | Distribution: Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053025 | JOSTRA HLM TUBING SET Maquet Cardiopulmonary, AG, Nov 10, 2005 |