Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,
- Company
- Abbott Vascular
- Recall Initiated
- March 25, 2020
- Terminated
- July 12, 2021
- Recall Number
- Z-2370-2020
- Quantity
- 13 units
- Firm Location
- Temecula, CA
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
Lot / Code Info
Lot Number: 903224A; Device Identifier/GTIN 08717648227455
Root Cause
Incorrect or no expiration date
Action Taken
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 AVRegulatoryCompliance@av.abbott.com; return a copy of this form with the returned product.