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Recall Observatory FDA recall evidence

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

August 13, 2014

Class II

Product summary

Firm
Volcano Corporation
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

    reason.sterility_assurance · v1.0.0

    breach to the sterile barrier