Medical device recalls Moderate risk

Prollenium Medical Technologies Inc. recalls Revanesse Versa, PN40081

Recall date
November 15, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1146-2020
FDA classification
Class II
Brand / firm
Prollenium Medical Technologies Inc.
Sold / distributed
US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA

Why it was recalled

Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Revanesse Versa, PN40081

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