Revanesse Versa, PN40081
Recall
- Recall Number
- Z-1146-2020
- Event Number
- 83834
- Firm
- Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada
- FEI Number
- 3004423487
- Product Code
- LMH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 15, 2018
- Terminated
- March 22, 2024
Description
Revanesse Versa, PN40081
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
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 shipping label that will allow you to send the product back to our distribution center. 2. Send email to info@prolIenium,com configured as follows: Business Name: XXX, Versa Lot #: XXX, Number of Expired Kits: XXX, Contact Person: XXX 3. Prollenium will inform you once the updated expiration date is approved by the US FDA.
US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
48,457 kits