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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84528

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

Open FDA event record

Event summary

Timeline bucket
February 08, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Riverpoint Medical, LLC

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

Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.

Z-0795-2020
Recall number
Z-0795-2020
Initiated
February 08, 2019
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
3,234 devices

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile grid packaging is potentially compromised

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

The integrity of the sterile grid packaging is potentially compromised.

Code information

Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.

Distribution pattern

Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.

Field note

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