FDA recall Z-1146-2020
Prollenium Medical Technologies Inc. · Class II · device
Product
Revanesse Versa, PN40081
Reason for recall
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Distribution
US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Key facts
- Status
- Terminated
- Initiation date
- 2018-11-15
- Report date
- 2020-02-19
- Termination date
- 2024-03-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Aurora, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2020