Recall Z-0604-2012 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.
| Date | Jan 11, 2012 (initiated Dec 7, 2011) |
| Status | Terminated |
| Reason | Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device. |
| Root cause | No Marketing Application |
| Action | 12/7/11 & 12/8/11 All consignees received a "Transition and Notification Guide" dated 12/6/11 and a "URGENT MEDICAL DEVICE REMOVAL" letter dated 12/4/11, which will inform them of the removal of the CD l 101 and provide the user with various options. Terumo will remove CD l 101 units from the US market over the next 18 months. |
| Quantity | 366 |
| Distribution | Nationwide Distribution - Including the states of: NV, MO, SC, WA, MI, FL, GA, NY, CT, IL, VA, NY, TN, IN, HI, TX, AL, OH, MD, AZ, CA, KS, MD, PA, and NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.