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Recall Observatory FDA recall evidence

Device 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,

Z-2370-2020

March 25, 2020

Class II

Product summary

Firm
Abbott Vascular
Event
Event 85497
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-2370-2020

Official wording

Reason: Incorrect expiration date

Code information: Lot Number: 903224A; Device Identifier/GTIN 08717648227455

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date