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U.S. Department of Health and Human Services

Class 2 Device Recall FlexFlowTM venous cannula Catalog 200200

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  Class 2 Device Recall FlexFlowTM venous cannula Catalog 200200 see related information
Date Initiated by Firm September 28, 2017
Create Date November 08, 2017
Recall Status1 Terminated 3 on October 17, 2018
Recall Number Z-0076-2018
Recall Event ID 78331
510(K)Number K052081  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product FlexFlow Venous Cannula Model/Catalog Number 200-200
The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
Code Information Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185
Recalling Firm/
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
Manufacturer Reason
for Recall
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
FDA Determined
Cause 2
Process change control
Action LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623.
Quantity in Commerce 40 units
Distribution Worldwide Distribution - US (nationwide) Internationally to France and Spain
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 = ESTECH, INC.