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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86347

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

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Event summary

Timeline bucket
August 13, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Battelle Memorial Institute

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

Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

Z-0309-2021
Recall number
Z-0309-2021
Initiated
August 13, 2020
Classification
Class II
Status
Terminated
Quantity
898

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

Code information

All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.

Distribution pattern

US Nationwide distribution including in the states of CT, MA, RI.