Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,
Recall
- Recall Number
- Z-2370-2020
- Event Number
- 85497
- Firm
- Abbott Vascular
- FEI Number
- 2024168
- Product Code
- NIQ
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- March 25, 2020
- Terminated
- July 12, 2021
- Address
- 26531 Ynez Rd, Temecula, CA, 92591-4630
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,
Incorrect expiration date
On March 25, 2020, the firm informed their customers that the firm has become aware that products were labeled with the incorrect expiration date. The firm sent an "Urgent Medical Device Recall" to customers. The recalled devices were shipped with a 36 months labeled expiration date, instead of 12 month expiration date. The firm is instructing customers to : - Review their inventory and immediately stop using devices from this lot - Complete and return the attached Effectiveness Check Form - Return all unused affected product to the firm. - Share this notification with other relevant personnel in their organization The firm requested customers to report any adverse reactions or quality problems to Customer Service Department at (800) 227-9902 and to return the "Effectiveness Check Form" to Customer Service Department at (800) 227-9902, scanned copy via E-mail to [email protected]; return a copy of this form with the returned product.
US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
13 units