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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 Device Recall ThinFlex Venous Return Cannulae see related information
Date Initiated by Firm July 14, 2008
Date Posted September 26, 2008
Recall Status1 Terminated 3 on December 23, 2008
Recall Number Z-2401-2008
Recall Event ID 49049
510(K)Number K831769  
Product Classification Cannula and Tubing Vascular Catheter - 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 UT 84047
For Additional Information Contact
801-565-6173
Manufacturer Reason
for Recall		 Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
FDA Determined
Cause 2		 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 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 = RESEARCH INDUSTRIES CORP.
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