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U.S. Department of Health and Human Services

Class 3 Device Recall Cuvette / Tubing Pack

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  Class 3 Device Recall Cuvette / Tubing Pack see related information
Date Initiated by Firm December 11, 2015
Create Date October 03, 2016
Recall Status1 Terminated 3 on October 26, 2016
Recall Number Z-0001-2017
Recall Event ID 75118
510(K)Number K915265  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product CDI¿ H/S Cuvette

The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

Code Information 6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various 
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information Contact
410-392-7277
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
FDA Determined
Cause 2
Other
Action Terumo (Planned Action) plans to execute the following steps as part of the correction activity: Notify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to a "disconnect" message on the monitor. This notification will be performed via a Customer Notification Letter. For further questions, please call (410) 392-7277.
Quantity in Commerce 140,000 units
Distribution Worldwide Distribution - USA (nationwide) Distribution.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = DRY and Original Applicant = 3M COMPANY
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