Z-2610-2011

CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101...

Name: Z-2610-2011 CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-04-28
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-04-28 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for... on 2011-04-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2610-2011
Status: Terminated
Initiated: 2011-04-28
Posted: 2011-06-22
Terminated: 2012-11-06
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA 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 1-800-521-2818, 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
Product codes and lots: Lot Number 1070-1839

Product code DRY

K902654Class IICdi (Tm) System 100 Monitoring System3M Health Care, Ltd. / cleared 1990-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)