Date Initiated by Firm |
June 14, 2019 |
Create Date |
July 30, 2019 |
Recall Status1 |
Terminated 3 on June 11, 2020 |
Recall Number |
Z-2101-2019 |
Recall Event ID |
83240 |
510(K)Number |
K180950
|
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
Product |
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE |
Code Information |
Lot Number: WP17 |
Recalling Firm/ Manufacturer |
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 |
16 units |
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
|