Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 Recalled by Edwards Lifesciences, LLC Due to Sterile catheter kit packaging compromised.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Quantity: 597 units
Why Was This Recalled?
Sterile catheter kit packaging compromised.
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, FL, GA, IL, IN, IA, KY, MD, MA, MO, SC, TN, TX, VA
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report