Recall Z-2370-2020 ยท NIQ Coronary Drug-Eluting Stent
Abbott Vascular
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,
| Date | Mar 25, 2020 |
| Status | Terminated |
| Reason | Incorrect expiration date |
| Root cause | Incorrect or no expiration date |
| Action | 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 perso |
| Quantity | 13 units |
| Distribution | US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.