FDA recall Z-2370-2020

Product

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

Reason for recall

Incorrect expiration date

Distribution

US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee

Key facts

Status

Terminated

Initiation date

2020-03-25

Report date

2020-06-24

Termination date

2021-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Temecula, CA, United States

Primary source

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