CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is in
FDA device recall Z-0604-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- DRY
- Quantity affected
- 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.
- Date initiated
- 2011-12-07
- Date posted
- 2012-01-11
- Date terminated
- 2013-08-30
- Location
- Ann Arbor, MI
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