FDAFDA · Food and drugs·Recall number Z-3103-2017
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Published September 13, 2017 · Recall initiated: August 7, 2017
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
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microvention, Inc.
- Distributor
- Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
- Lot
- Lot numbers 17030521, 17032821, and 17041831
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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