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Terminated

CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

FDA Recall Z-0675-2012 · Posted 2012-01-11

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDRY
Date Initiated2011-12-06
Date Terminated2013-03-01
Product Quantity451 units total

Reason for Recall

In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented: Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all

Firm Action

Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 6, 2011. The letter identified the affected products, the problem, and the actions to be taken by customer/user. The letter states that Terumo CVS will update all affected CDl Monitors and no additional actions are necessary for those units previously returned that received the correction as part of the service process. For questions or concerns contact Terumo CVS Customer Service 1-800-521-2818.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - USA (nationwide in the states of: AR, AZ, CA, FL, KS, IL, IN, LA, MA, MO, MI, MS, NJ, NV, NC, OH, PA, TN, TX, VA, WA, WI, WV including Puerto Rico and the countries of: AE, Australia, BR, Belgium, Brazil, Canada, China, Dominican Republic, EC, Germany, Guatemala, Japan, Korea, Mexico, SA, Taiwan and UY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K9729623M CDI BLOOD PARAMETER MONITORING SYSTEM 5003M Company · 1997-11-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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