Edwards Lifesciences, LLC Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Brand
Edwards Lifesciences, LLC
Lot Codes / Batch Numbers
Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
Products Sold
Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
Edwards Lifesciences, LLC is recalling Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 due to Sterile catheter kit packaging compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterile catheter kit packaging compromised.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, IL, IN, IA, KY, MD, MA, MO, SC, TN, TX, VA
Page updated: Jan 10, 2026