|
Class 2 Device Recall Aortic Perfusion Cannula |
|
Date Initiated by Firm |
March 07, 2018 |
Create Date |
September 13, 2018 |
Recall Status1 |
Terminated 3 on November 27, 2018 |
Recall Number |
Z-3027-2018 |
Recall Event ID |
80317 |
510(K)Number |
K123370
|
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product |
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. |
Code Information |
Code Number AAO24TFA-R; Lot Number 59736014; Serial Numbers 16504192017-01, 16504192017-02, 16504192017-03, 16504192017-04, 16504192017-05, 16504192017-06, 16504192017-07, 16504192017-08, 16504192017-09, 16504192017-10 |
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 |
10 units 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.
|
|
|
|