Reported Jul 1, 2015 · Terminated
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation…
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 PV .035
- CatheterPart
- number88901
- Product UsageThe Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image
- Lot codes and dates
Product number 88901lot number 50002518
- Amount recalled
- 162 total devices (included both products)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
This product could cause temporary or reversible health problems — stop using it.
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