Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,

FDA Recall Z-2370-2020 · Posted None

Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeNIQ
Date Initiated2020-03-25
Date Terminated2021-07-12
Product Quantity13 units

Reason for Recall

Incorrect expiration date

Firm 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 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑