Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Reported: July 6, 2022 Initiated: May 13, 2022 #Z-1301-2022
Product Description
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Reason for Recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Details
- Recalling Firm
- Volcano Corp
- Units Affected
- 14.031 units
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797. Recalled by Volcano Corp. Units affected: 14.031 units.
Why was this product recalled? ▼
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Low. Recall number: Z-1301-2022.
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