Recall Z-2610-2011 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.
| Date | Jun 22, 2011 (initiated Apr 28, 2011) |
| Status | Terminated |
| Reason | Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation. |
| Root cause | Device Design |
| Action | Terumo Cardiovascular Systems, Corp issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer. After a solution has been verified, Terumo CVS will implement a correction for all affected units. Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form. For further question please contact Terumo CVS Customer Service at 1 |
| Quantity | 622 |
| Distribution | Worldwide Distribution -- USA ( nationwide) and the countries of Colombia, Vietnam, India, Indonesia, Pakistan, Canada, Chile, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Singapore, Taiwan, Belgium, Thailand, Vietnam and India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM 3M Health Care, Ltd., Nov 5, 1990 |