FDA Device recall Z-1146-2020
Revanesse Versa, PN40081
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Revanesse Versa, PN40081 by Prollenium Medical Technologies, citing labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1146-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-15 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Prollenium Medical Technologies |
| Distribution | US |
Product
Revanesse Versa, PN40081
Reason
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Identifiers
| code_info | Lot #/ Exp. date 17K004/July 31, 2018 17K005/July31,2018 I7K006/August 31, 2018 17K007/August 31, 2018 17K09…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2020%22
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