Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas s
FDA device recall Z-1944-2011 · posted 2011-04-11 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
- Action taken
- On 11/1/2010, Terumo sent "URGENT MEDICAL DEVICE CORRECTION" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operators manual.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTY
- Quantity affected
- 1032 units
- Distribution
- US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand.
- Date initiated
- 2010-11-01
- Date posted
- 2011-04-11
- Date terminated
- 2012-04-17
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654) | 3M Health Care, Ltd. | 1990-11-05 |