Z-1301-2022 Class III Ongoing
FDA device recall Z-1301-2022 was initiated by Volcano Corp on May 13, 2022 and is designated Class III. Reason for recall: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications The recall status is ongoing. Affected quantity: 14.031 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- May 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14.031 units
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
Distribution Pattern
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.
Code Information
All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329