FDAFDA · Food and drugs·Recall number Z-2636-2014
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Published September 24, 2014 · Recall initiated: August 13, 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
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corporation
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
- Lot
- Part number 91003: All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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