CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary bypass procedures.

FDA device recall Z-1382-2012 · posted 2012-04-06 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.

Action taken

On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovascular Systems representative or call 1-800-521-2818 with questions or concerns, to check the last time system batteries were replaced, or to schedule maintenance for systems approaching 10 years.

Root cause

Labeling design

Status

Terminated

Product code

DRY

Quantity affected

3,829 total units distributed

Distribution

Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, O

Date initiated

2012-02-03

Date posted

2012-04-06

Date terminated

2013-08-29

Location

Ann Arbor, MI

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