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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves

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  Class 2 Device Recall Custom Cardiovascular Procedure Kits; OverPressure Safety Valves see related information
Date Initiated by Firm May 06, 2015
Date Posted June 23, 2015
Recall Status1 Terminated 3 on July 27, 2015
Recall Number Z-1828-2015
Recall Event ID 71196
510(K)Number K820297  
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves.

For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Code Information Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.
Quantity in Commerce 163 devices
Distribution Distributed to the states of MO and FL.
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 = DTL and Original Applicant = C.R. BARD, INC.
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