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U.S. Department of Health and Human Services

Class 2 Device Recall Capiox NX19 Oxygenator

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  Class 2 Device Recall Capiox NX19 Oxygenator see related information
Date Initiated by Firm June 14, 2019
Create Date July 30, 2019
Recall Status1 Terminated 3 on June 11, 2020
Recall Number Z-2102-2019
Recall Event ID 83240
510(K)Number K180950  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation)
Code Information Lot Numbers: XAl 1, XA28, XC07
Recalling Firm/
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
Manufacturer Reason
for Recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
FDA Determined
Cause 2
Process control
Action Terumo issued Urgent Medical Device Notification letter dated June 13 2019 via FedEx mailing executed on 6/14/2019 advising of the problem, health risk and action to take: Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Questions or concerns: ¿ Terumo CVS Customer Service: 1.800.521.2818 Monday  Friday, 8 a.m.  6 p.m. ET ¿ Terumo Recall Fax: 1.410.392.7183 ¿ Terumo Recall Email: TCVSCustomerResponseElkton@terumomedical.com
Quantity in Commerce 52units
Distribution MI Foreign: Japan, Belgium
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 = DTZ and Original Applicant = Terumo Cardiovascular Systems Corporation