FDA-Device2020-06-24Class II

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,

Abbott Vascular
Hazard

Incorrect expiration date

Sold states
US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
Affected count
13 units
Manufactured in
26531 Ynez Rd, Temecula, CA, United States
Products
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2370-2020

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