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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Capiox NX19 Oxygenator

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 Class 2 Device Recall Terumo Capiox NX19 Oxygenatorsee related information
Date Initiated by FirmJune 14, 2019
Create DateJuly 30, 2019
Recall Status1 Terminated 3 on June 11, 2020
Recall NumberZ-2103-2019
Recall Event ID 83240
510(K)NumberK180950 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductTerumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Code Information Lot Numbers: XA28, XC12, XC25, 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
ActionTerumo 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 Commerce78 units
DistributionMI Foreign: Japan, Belgium
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTZ
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