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U.S. Department of Health and Human Services

Class 2 Device Recall Conducer Cardioplegia Set SITH MP4

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  Class 2 Device Recall Conducer Cardioplegia Set SITH MP4 see related information
Date Initiated by Firm March 01, 2011
Date Posted October 31, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0160-2015
Recall Event ID 58185
510(K)Number K922992  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Terumo Custom Cardioplegia Delivery Set-
Catalog Number:165720 and Catalog Number: 6375

Product Usage:
Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.
Code Information Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0.  Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3  Manufacturing dates March 15, 2010 through December 13, 20 I 0
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		 Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
FDA Determined
Cause 2		 Device Design
Action Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.
Quantity in Commerce Catalog: 16579 ; Catalog 6375: 3256 units
Distribution Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
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 = DWF and Original Applicant = 3M HEALTH CARE, LTD.
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