FDA Device Recall Z-0001-2017: Terumo Cardiovascular Systems Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2017.

Recall Res Number

Z-0001-2017

Recalling Firm / Manufacturer

Terumo Cardiovascular Systems Corporation

FEI Number

3000204839

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-12-11

Date Posted

N/A

Date Terminated

2016-10-26

Product Code

DRY

Event Number

75118

Product Quantity

140,000 units

Product Description 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.

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.

Action Details 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.

Distribution Pattern Worldwide Distribution - USA (nationwide) Distribution.

Code Information / Serial Numbers 6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

Related Establishments / Registrations

TERUMO MEDICAL CORP. Registration: 1118880 View Registration
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Registration: 1124841 View Registration
Philips North America LLC Registration: 1218950 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION Registration: 1828100 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 View Registration
Sterigenics U.S., LLC Registration: 2245590 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
MEDTRONIC B.V. (EOC) Registration: 3002807561 View Registration
SPECTRUM MEDICAL LTD Registration: 3006073153 View Registration
ORGANOX LIMITED Registration: 3011560054 View Registration
Philips North America LLC Registration: 3016618143 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
DSV CONTRACT LOGISTICS Registration: 3044156918 View Registration
LivaNova Deutschland GmbH Registration: 9611109 View Registration
Medtronic Mexico S. de R.L. de CV Registration: 9617601 View Registration
SORIN GROUP ITALIA S.R.L Registration: 9680841 View Registration

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Medical Device Recall: Z-0001-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer