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Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Recalled July 6, 2022 · FDA recall Z-1301-2022 · Volcano
Hazard
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications · FDA Class III
Units
14.031 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
Description
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Manufacturer(s)
Volcano Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →