Device product
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.
Z-2636-2014
Product summary
- Event
- Event 69049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8251 total devices (3777 US)
- Official record key
device-enforcement:Z-2636-2014
Official wording
Reason: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Code information: Part number 91003: All Lots
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
Derived failure modes
-
Sterility assurance
breach to the sterile barrier