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.
Reported: September 24, 2014 Initiated: August 13, 2014 #Z-2636-2014
Product Description
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.
Reason for Recall
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Details
- Recalling Firm
- Volcano Corporation
- Units Affected
- 8251 total devices (3777 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
- Location
- Rancho Cordova, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Volcano Corporation. Units affected: 8251 total devices (3777 US).
Why was this product recalled? ▼
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2014. Severity: Moderate. Recall number: Z-2636-2014.
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