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U.S. Department of Health and Human Services

Class 2 Device Recall THINFLEX VENOUS CANNULA TF292902A

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  Class 2 Device Recall THINFLEX VENOUS CANNULA TF292902A see related information
Date Initiated by Firm November 04, 2015
Date Posted December 09, 2015
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-0398-2016
Recall Event ID 72667
510(K)Number K120072  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Thin-Flex Venous Cannula, Model Number:TF292902A
Code Information Lot No:  59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Sherri Robbins
801-553-7531
Manufacturer Reason
for Recall		 Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
FDA Determined
Cause 2		 Employee error
Action Edwards Lifesciences sent an Urgent Medical Device Safety Notice dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Instructions 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your hospital. 3. Complete and return the acknowledgement form attached to this letter via fax to (800) 422-9329 within 5 business days of receiving this notice. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. 5. Product return is not required. Actual product is acceptable for use and is not being recalled as part of this field action. Your assistance is appreciated and necessary to ensure that this notice is reviewed and understood. We appreciate your attention, and apologize for the inconvenience caused by this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service Monday through Friday at (800) 424-3278 from 8:00AM - 4:00PM Pacific Time.
Quantity in Commerce 8,915 units
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
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 = EDWARDS LIFESCIENCES, LLC.
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