FDA-Device2021-06-23Class I
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.
Medtronic Vascular
Hazard
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.
Sold states
US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia
Affected count
54,997 units
Manufactured in
35-37A Cherry Hill Drive, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2021Don't want to check this manually?
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