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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiopulmonary Bypass Catheter Cannula and Tubing

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  Class 2 Device Recall Cardiopulmonary Bypass Catheter Cannula and Tubing see related information
Date Initiated by Firm June 09, 2017
Create Date August 10, 2017
Recall Status1 Open3, Classified
Recall Number Z-2871-2017
Recall Event ID 77699
510(K)Number K943934  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile

Product Usage:
The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Information Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Joan Ceasar
281-228-7260
Manufacturer Reason
for Recall
Identification of excess plastic on the tip of the cannula.
FDA Determined
Cause 2
Process control
Action LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement.
Quantity in Commerce 105,770 units
Distribution Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.
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