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U.S. Department of Health and Human Services

Class 3 Device Recall ThinFlex Venous Return Cannulae

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 Class 3 Recall
ThinFlex Venous Return Cannulae
see related information
Date Posted September 26, 2008
Recall Status1 Terminated on December 23, 2008
Recall Number Z-2401-2008
Recall Event ID 49049
Premarket Notification
510(K) Number
K831769 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
Code Information Lot Number 58449974
Recalling Firm/
Manufacturer
Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale, Utah 84047
Manufacturer Reason
for Recall
Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.
Quantity in Commerce 707 units
Distribution Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = RESEARCH INDUSTRIES CORP.
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