Date Initiated by Firm | June 14, 2019 |
Create Date | July 30, 2019 |
Recall Status1 |
Terminated 3 on June 11, 2020 |
Recall Number | Z-2104-2019 |
Recall Event ID |
83240 |
510(K)Number | K180950 |
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
Product | Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281
Exported only to Japan for inclusion into convenience kits that are sold only
within the Japanese market |
Code Information |
Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27 |
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 | 123 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.
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510(K) Database | 510(K)s with Product Code = DTZ
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