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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86764

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

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Event summary

Timeline bucket
November 05, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries 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

RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.

Z-0615-2021
Recall number
Z-0615-2021
Initiated
November 05, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
15,780

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RevMedX Trauma Dressing is being recalled due to package seal integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

RevMedX Trauma Dressing is being recalled due to package seal integrity.

Code information

Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023

Distribution pattern

Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.