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Class 2 Device Recall Cardiopulmonary Bypass Catheter Cannula and Tubing |
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Date Initiated by Firm |
June 09, 2017 |
Create Date |
August 10, 2017 |
Recall Status1 |
Terminated 3 on November 09, 2023 |
Recall Number |
Z-2871-2017 |
Recall Event ID |
77699 |
510(K)Number |
K943934
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Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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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.
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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
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For Additional Information Contact |
Joan Ceasar 281-228-7260
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Manufacturer Reason for Recall |
Identification of excess plastic on the tip of the cannula.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.
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