Volcano Corp Recall 90252
Description: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Volcano Corp Recall 90252 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1301-2022 |
| Event ID | 90252 |
| Event Description | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 14.031 units |
| Recall Reason | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| Device Classification | 20220706 |
| Device Code Info | All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329 |
| Center Classification Date | 20220629 |
| Recall Initiation Date | 20220513 |
| Recalling Firm | Volcano Corp |
| Initial Notification | Letter |
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