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U.S. Department of Health and Human Services

Class 2 Device Recall HemoSphere Oximetry Cable

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  Class 2 Device Recall HemoSphere Oximetry Cable see related information
Date Initiated by Firm October 07, 2019
Date Posted May 08, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1928-2020
Recall Event ID 85409
510(K)Number K163381  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Code Information The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100. 
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Mr. Michael Collins
949-250-6827
Manufacturer Reason
for Recall
Intermittent communication due to inconsistent crimping of connectors onto cables.
FDA Determined
Cause 2
Process control
Action On xx/xx/2019, and URGENT MEDICAL DEVICE RECALL-ACTION REQUIRED, letter was sent to customers by FedEx. Customers are instructed to acknowledge this notification , contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number and to return all product to recalling firm.
Quantity in Commerce 35
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
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 = DQK and Original Applicant = Edwards Lifesciences, LLC
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