FDAFDA · Food and drugs·Recall number Z-0162-2015
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Published November 12, 2014 · Recall initiated: September 26, 2014
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
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Nationwide and to India. No govt/military/VA consignees.
- Lot
- Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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