FDAFDA · Food and drugs·Recall number Z-0614-2014
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Published January 8, 2014 · Recall initiated: December 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Lot
- Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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