Z-2370-2020 Class II Terminated
FDA device recall Z-2370-2020 was initiated by Abbott Vascular on March 25, 2020 and is designated Class II. Reason for recall: Incorrect expiration date The recall status is terminated (terminated July 12, 2021). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- March 25, 2020
- Termination Date
- July 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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
Distribution Pattern
US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
Code Information
Lot Number: 903224A; Device Identifier/GTIN 08717648227455