Reported Sep 24, 2014 · Terminated
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
- 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.
- Lot codes and dates
- Part number 91003All Lots
- Amount recalled
- 8251 total devices (3777 US)
Where it was sold
- Nationwide
Why it was recalled
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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