Recall Z-0142-2012 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 50
| Date | Oct 31, 2011 (initiated Sep 23, 2011) |
| Status | Terminated |
| Reason | Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored. |
| Root cause | Component design/selection |
| Action | Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for quest |
| Quantity | 432 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 3M Company, Nov 6, 1997 |