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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Venous Cannula

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  Class 2 Device Recall Femoral Venous Cannula see related information
Date Initiated by Firm March 07, 2018
Create Date September 13, 2018
Recall Status1 Terminated 3 on November 27, 2018
Recall Number Z-3033-2018
Recall Event ID 80317
510(K)Number K140208  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
Code Information Code Number VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01 
Recalling Firm/
Manufacturer		 SPS Sterilization, Inc
1110 N Gerald St
Nixa MO 65714-7445
For Additional Information Contact Steven M. Darocy
412-564-1280
Manufacturer Reason
for Recall		 The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
Quantity in Commerce 1 unit total
Distribution US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
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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