FDA-Device2020-05-20Class II
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Edwards Lifesciences, LLC
Hazard
Sterile catheter kit packaging compromised.
Sold states
US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Affected count
597 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2007-2020Don't want to check this manually?
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