Device product
Revanesse Versa, PN40081
Z-1146-2020
Product summary
- Event
- Event 83834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,457 kits
- Official record key
device-enforcement:Z-1146-2020
Official wording
Reason: Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Code information: 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
Distribution pattern: US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Derived failure modes
-
Labeling or packaging
Labeling error