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U.S. Department of Health and Human Services

Class 2 Device Recall CAPIOX FX Hollow Fiber Oxygenator

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  Class 2 Device Recall CAPIOX FX Hollow Fiber Oxygenator see related information
Date Initiated by Firm April 12, 2012
Date Posted May 11, 2012
Recall Status1 Terminated 3 on January 23, 2013
Recall Number Z-1528-2012
Recall Event ID 61644
510(K)Number K071494  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Cardiovascular Custom Procedure Kit Adult
Product Code: 71060-01
Code Information Lot No: MH12 ;  MK23 ;  MP20;  NC21 ;  NK22    
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact SAME
508-231-2400
Manufacturer Reason
for Recall		 Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
Quantity in Commerce 22 units
Distribution Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
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 CORP.
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