CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for u

FDA device recall Z-0674-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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

Action taken

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

Status

Terminated

Product code

DRY

Quantity affected

451 units total

Distribution

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, Au

Date initiated

2011-12-06

Date posted

2012-01-11

Date terminated

2013-03-01

Location

Ann Arbor, MI

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