Reported Feb 19, 2020 · Terminated

Revanesse Versa, PN40081

Prollenium Medical Technologies Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Prollenium Medical Technologies Inc. · 138 Industrial Pky N · Aurora · N/A

Is this the product you have?

  • Revanesse Versa, PN40081
Lot codes and dates
    • Lot #/ Exp. date 17K004/July 31
    • 2018 17K005/July31
    • 2018 I7K006/August 31
    • 2018 17K007/August 31
    • 2018 17K090/October 31
    • 2018 17K091/October 31
    • 2018 17L026/October 31
    • 2018 17L028/October 31
    • 2018 I7L050/November 30
    • 2018 17L0S1/November 30
    • 2018 18A023/November 30
    • 2018 18A024/November 30
    • 2018 I8E028/December 31
    • 2018 18E029/December 31
    • 2018 18F032/December 31
    • 2018 18F033/December 31
    • 2018 18G065/April 30
    • 2019 18G074/April 30
    • 2019 18G075/April 30
    • 2019 18G076/April 30
    • 2019 181022/June 30
    • 2019 181029/June 30
    • 2019
Amount recalled
48,457 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2024 · Data as of Sep 19, 5:32 PM UTC

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