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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88345

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

Open FDA event record

Event summary

Timeline bucket
April 26, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Northeast Scientific 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

NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

Z-2334-2021
Recall number
Z-2334-2021
Initiated
April 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
Northeast Scientific Inc.
Quantity
690 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

Code information

Lots L0017886 through L0020553

Distribution pattern

US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.