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 312018 17K005/July312018 I7K006/August 312018 17K007/August 312018 17K090/October 312018 17K091/October 312018 17L026/October 312018 17L028/October 312018 I7L050/November 302018 17L0S1/November 302018 18A023/November 302018 18A024/November 302018 I8E028/December 312018 18E029/December 312018 18F032/December 312018 18F033/December 312018 18G065/April 302019 18G074/April 302019 18G075/April 302019 18G076/April 302019 181022/June 302019 181029/June 302019
- 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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