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U.S. Department of Health and Human Services

Class 2 Device Recall OXIMETER CATHETER KIT

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  Class 2 Device Recall OXIMETER CATHETER KIT see related information
Date Initiated by Firm March 27, 2020
Date Posted July 10, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-2007-2020
Recall Event ID 85483
510(K)Number K172423  
Product Classification Catheter, oximeter, fiber-optic - Product Code DQE
Product Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Code Information Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Ms. Linnette Torres
949-250-4582
Manufacturer Reason
for Recall		 Sterile catheter kit packaging compromised.
FDA Determined
Cause 2		 Under Investigation by firm
Action Recall is to the customer level. URGENT MEDICAL DEVICE RECALL- ACTION REQUIRED letter, via FedEx, along with an acknowledgment form will be sent to all customers possessing any of the affected units. Letters will be sent overnight via FedEx. Customers will be instructed to acknowledge the 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 the recalling firm.
Quantity in Commerce 597 units
Distribution US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
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 = DQE and Original Applicant = Edwards Lifescience LLC
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