Recall Z-1146-2020 ยท LMH Implant, Dermal, For Aesthetic Use
Prollenium Medical Technologies Inc.
Revanesse Versa, PN40081
| Date | Nov 15, 2018 |
| Status | Terminated |
| Reason | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
| Root cause | Other |
| Action | A letter containing the subject "Revanesse Versa Expiration Dating" was e-mail on Nov 15, 2018 and April 30, 2019 to all consignees. The letter informed consignees about the issue. The letter asked consignees to do the following: 1. We request you to verily if any Revanesse Versa kit lots listed in the table on Page 2 are in your possession, if so please set aside and do not use them if they are expired from their 12 month expiration date has passed. If you have any concerns with your existing Revanesse Versa kits, please ^ contact Prollenium with the information below. We will send you a sh |
| Quantity | 48,457 kits |
| Distribution | US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.