Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2021