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Class 2 Device Recall EZ Glide Aortic Cannula |
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Date Initiated by Firm |
March 07, 2018 |
Create Date |
September 13, 2018 |
Recall Status1 |
Terminated 3 on November 27, 2018 |
Recall Number |
Z-3028-2018 |
Recall Event ID |
80317 |
510(K)Number |
K123370
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Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product |
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. |
Code Information |
Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37 |
Recalling Firm/ Manufacturer |
SPS Sterilization, Inc 1110 N Gerald St Nixa MO 65714-7445
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For Additional Information Contact |
Steven M. Darocy 412-564-1280
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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.
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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 |
6 units total |
Distribution |
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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