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U.S. Department of Health and Human Services

Class 2 Device Recall Dual Stage Venous Return Catheter

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  Class 2 Device Recall Dual Stage Venous Return Catheter see related information
Date Initiated by Firm January 25, 2016
Date Posted February 16, 2016
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-0813-2016
Recall Event ID 73224
510(K)Number K943934  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
Code Information lot - 1529300018
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Carrie Wood
303-467-6306
Manufacturer Reason
for Recall		 Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
FDA Determined
Cause 2		 Employee error
Action LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail USFieldSafetyActions@livanova.com. We sincerely apologize for this inconvenience and thank you in advance for your support
Quantity in Commerce 60
Distribution US Distribution to CA., and Internationally to 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 = DWF and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.
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