The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr
FDA device recall Z-1689-2023 · posted 2023-06-06 · Open, Classified
Recall details
- Recalling firm
- Bolton Medical Inc.
- Reason for recall
- Potential for the incorrect size stent-graft than the printed carton label.
- Action taken
- Bolton Medical notified consignees via letter delivered through USPS Certified delivery, on 05/03/2023. Consignees were instructed to examine inventory and quarantine any affected units, complete and return the Acknowledgement Form, arrange for the return of affected units, and maintain a copy of the notification for your records.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MIH
- Quantity affected
- 216 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
- Date initiated
- 2023-05-03
- Date posted
- 2023-06-06
- Location
- Sunrise, FL
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