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Recall Observatory FDA recall evidence

Device product

Revanesse Versa, PN40081

Z-1146-2020

November 15, 2018

Class II

Product summary

Firm
Prollenium Medical Technologies Inc.
Event
Event 83834
Status
Terminated
Classification
Class II
Quantity
48,457 kits
Official record key
device-enforcement:Z-1146-2020

Official wording

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

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error