FDA-Device2022-06-22Class II
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Volcano Corp
Hazard
Due to a potential failed sterilization process.
Sold states
U.S.: WA and WI O.U.S.: Canada
Affected count
11 devices
Manufactured in
3721 Valley Centre Dr Ste 500, San Diego, CA, United States
Products
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2022Don't want to check this manually?
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