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Prollenium Medical Technologies Inc. recalls Revanesse Versa, PN40081
Recalled February 19, 2020 · FDA recall Z-1146-2020 · Prollenium Medical Technologies
Hazard
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. · FDA Class II
Units
48,457 kits
Sold at
US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Description
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Product
Revanesse Versa, PN40081
Manufacturer(s)
Prollenium Medical Technologies Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →