Prollenium Medical Technologies Inc.: Medical Device Recall in 2020 - (Recall #: Z-1146-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Revanesse Versa, PN40081

Product Classification:

Class II

Date Initiated: November 15, 2018

Date Posted: February 19, 2020

Recall Number: Z-1146-2020

Event ID: 83834

Reason for Recall:

Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

Status: Terminated

Product Quantity: 48,457 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated