FDA-Device2020-02-19Class II
Revanesse Versa, PN40081
Prollenium Medical Technologies Inc.
Hazard
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Sold states
US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Affected count
48,457 kits
Manufactured in
138 Industrial Pky N, Aurora, Canada
Products
Revanesse Versa, PN40081
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2020Don't want to check this manually?
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