Recall Z-2370-2020— Abbott Vascular
Class II · Terminated
Class II FDA medical device recall by Abbott Vascular, initiated 2020-03-25, terminated 2021-07-12. FDA's recall record names no specific 510(k) clearance for this event. 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: Incorrect expiration date.
- Recalling firm
- Abbott Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-25
- Terminated
- 2021-07-12
- Firm location
- Temecula, CA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.