FDA Medical Device Recalls (openFDA)
Prollenium Medical Technologies Inc.: Revanesse Versa, PN40081
- Recall number
- Z-1146-2020
- Recalling firm
- Prollenium Medical Technologies Inc.
- Product
- Revanesse Versa, PN40081
- Status
- Terminated
- Initiated
- 2018-11-15
- Posted
- not on file
- Terminated
- 2024-03-22
- 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 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.
- Quantity
- 48,457 kits
- Distribution
- US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P160042"]
- Product code
- LMH
- Firm FEI
- 3004423487
- Firm city
- Aurora
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28