| Class 2 Device Recall CDITM 101 Monitor | |
Date Initiated by Firm | April 28, 2011 |
Date Posted | June 22, 2011 |
Recall Status1 |
Terminated 3 on November 06, 2012 |
Recall Number | Z-2610-2011 |
Recall Event ID |
58779 |
510(K)Number | K902654 |
Product Classification |
monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
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Product | 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. |
Code Information |
Lot Number 1070-1839 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | Tracy Bellanca 734-741-6173 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST. |
Quantity in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DRY
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