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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83834

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 15, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Prollenium Medical Technologies Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Revanesse Versa, PN40081

Z-1146-2020
Recall number
Z-1146-2020
Initiated
November 15, 2018
Classification
Class II
Status
Terminated
Quantity
48,457 kits

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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